Michele B. Kaufman, PharmD, BSc, RPh

Changed

Fri, 09/14/2018 - 12:29

Display Headline

Market Watch

Author(s)

New Generics

Atomoxetine capsules (Strattera)¹

Clonidine transdermal system USP (catapres-TTS)²

Enoxaparin sodium injection (Lovenox)³

Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.

Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.

Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷

Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸

Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.

Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰

Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹

Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²

Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³

Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴

Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.

STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.

Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷

Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.

Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.

Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.

Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.

First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.

Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.

Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.

Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.

MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.

NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.

Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.

Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.

Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.

Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.

Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.

Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.

Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.

Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.

FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.

FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.

FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

Issue

The Hospitalist - 2010(12)

Publications

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generics

Atomoxetine capsules (Strattera)¹

Clonidine transdermal system USP (catapres-TTS)²

Enoxaparin sodium injection (Lovenox)³

Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.

Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.

Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷

Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸

Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.

Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰

Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹

Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²

Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³

Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴

Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.

STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.

Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷

Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.

Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.

Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.

Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.

First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.

Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.

Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.

Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.

MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.

NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.

Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.

Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.

Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.

Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.

Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.

Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.

Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.

Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.

FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.

FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.

FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

New Generics

Atomoxetine capsules (Strattera)¹

Clonidine transdermal system USP (catapres-TTS)²

Enoxaparin sodium injection (Lovenox)³

Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.

Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.

Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷

Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸

Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.

Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰

Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹

Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²

Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³

Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴

Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.

STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.

Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷

Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.

Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.

Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.

Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.

First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.

Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.

Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.

Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.

MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.

NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.

Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.

Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.

Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.

Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.

Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.

Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.

Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.

Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.

FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.

FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.

FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

Issue

The Hospitalist - 2010(12)

Issue

The Hospitalist - 2010(12)

Publications

Publications

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:29

Display Headline

Market Watch

Author(s)

New Drugs, Devices, Indications, and Approvals

Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.¹

Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.²

Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.³ It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.

Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.⁴ It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.

Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).⁵ This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.

Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.⁶

Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.⁷

Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.⁸

Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.⁹ The original approval of ranibizumab was for wet age-related macular degeneration.

Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.¹⁰

Pipeline

Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.¹¹ Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.

The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.¹² Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.

Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.¹³ Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.

TC-5214 has begun Phase 3 clinical trials.¹⁴ It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.

An NDA for vilazodone has been filed for treating major depressive disorder.¹⁵ It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.¹⁶ Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.

Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).¹⁷ This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.

Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.

Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.

Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.

Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.

FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.

Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.

ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.

Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.

Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.

Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.

FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.

Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.

AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.

Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.

FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

Issue

The Hospitalist - 2010(11)

Publications

Topics

Patient Safety

Read more about Market Watch

Sections

Author(s)

Author(s)

New Drugs, Devices, Indications, and Approvals

Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.¹

Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.²

Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.³ It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.

Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.⁴ It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.

Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).⁵ This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.

Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.⁶

Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.⁷

Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.⁸

Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.⁹ The original approval of ranibizumab was for wet age-related macular degeneration.

Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.¹⁰

Pipeline

Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.¹¹ Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.

The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.¹² Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.

Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.¹³ Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.

TC-5214 has begun Phase 3 clinical trials.¹⁴ It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.

An NDA for vilazodone has been filed for treating major depressive disorder.¹⁵ It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.¹⁶ Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.

Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).¹⁷ This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.

Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.

Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.

Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.

Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.

FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.

Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.

ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.

Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.

Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.

Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.

FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.

Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.

AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.

Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.

FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

New Drugs, Devices, Indications, and Approvals

Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.¹

Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.²

Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.³ It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.

Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.⁴ It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.

Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).⁵ This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.

Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.⁶

Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.⁷

Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.⁸

Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.⁹ The original approval of ranibizumab was for wet age-related macular degeneration.

Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.¹⁰

Pipeline

Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.¹¹ Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.

The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.¹² Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.

Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.¹³ Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.

TC-5214 has begun Phase 3 clinical trials.¹⁴ It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.

An NDA for vilazodone has been filed for treating major depressive disorder.¹⁵ It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.¹⁶ Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.

Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).¹⁷ This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.

Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.

Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.

Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.

Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.

FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.

Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.

ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.

Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.

Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.

Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.

FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.

Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.

AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.

Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.

FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

Issue

The Hospitalist - 2010(11)

Issue

The Hospitalist - 2010(11)

Publications

Publications

Topics

Patient Safety

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:29

Display Headline

Market Watch

Author(s)

New Generics

Anastrazole tablets (generic Arimidex)¹

Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²

Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³

Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴

Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵

Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶

Tacrolimus 5-mg capsules (generic Prograf)⁷

Trandolapril/verapamil tablets (generic Tarka)⁸

Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹

Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.

Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.

Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³

Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.

HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.

Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

GlaxoSmithKline has received reports of dispensing errors related to rosiglitazone (Avandia), glimepiride (Amaryl), rosiglitazone/metformin (Avandamet), candesartan (Atacand), and warfarin (Coumadin). In some instances, the patient received the wrong medication (one severe case led to impaired mental status). Errors likely occurred due to illegible written prescriptions and/or incorrectly interpreted, labeled, and filled prescriptions. Some of these products have similar dosage strengths and also look alike, leading to the errors.²¹

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.

Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.

APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.

Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.

Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.

Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.

Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.

Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.

Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.

Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.

Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.

Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.

Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.

FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.

Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.

FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.

Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.

Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.

Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.

Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.

Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.

New Jersey State Board of Pharmacy News, April 2010;24:2-3.

Issue

The Hospitalist - 2010(10)

Publications

Topics

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generics

Anastrazole tablets (generic Arimidex)¹

Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²

Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³

Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴

Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵

Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶

Tacrolimus 5-mg capsules (generic Prograf)⁷

Trandolapril/verapamil tablets (generic Tarka)⁸

Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹

Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.

Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.

Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³

Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.

HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.

Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.

Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.

APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.

Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.

Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.

Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.

Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.

Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.

Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.

Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.

Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.

Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.

Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.

FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.

Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.

FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.

Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.

Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.

Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.

Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.

Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.

New Jersey State Board of Pharmacy News, April 2010;24:2-3.

New Generics

Anastrazole tablets (generic Arimidex)¹

Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²

Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³

Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴

Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵

Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶

Tacrolimus 5-mg capsules (generic Prograf)⁷

Trandolapril/verapamil tablets (generic Tarka)⁸

Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹

Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.

Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.

Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³

Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.

HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.

Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.

Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.

APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.

Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.

Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.

Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.

Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.

Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.

Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.

Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.

Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.

Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.

Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.

FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.

Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.

FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.

Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.

Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.

Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.

Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.

Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.

New Jersey State Board of Pharmacy News, April 2010;24:2-3.

Issue

The Hospitalist - 2010(10)

Issue

The Hospitalist - 2010(10)

Publications

Publications

Topics

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:30

Display Headline

Market Watch

Author(s)

New Drugs, Indications, Dosage Forms, and Approval Recommendations

Acetaminophen intravenous (Ofirmev) received a complete response letter in February from the FDA related to facility manufacturing deficiencies. The FDA did not cite any safety or efficacy issues and is not requiring any additional studies to be done prior to approval.¹ The third-party manufacturer has submitted its response to the FDA and is ready to resubmit their new drug application (NDA) for this agent. It is being investigated to treat fever and pain in adults and children.²

Ciprofloxacin dry powder inhaler (DPI) has received orphan drug status from the FDA for treating pulmonary infections in cystic fibrosis (CF) patients.^3,4 It is in clinical trials to determine if it can improve pulmonary function in CF patients with Pseudomonas aeruginosa infections.

Carglumic acid (Carbaglu) has been approved by the FDA to treat the metabolic disorder N-acetylglutamate synthetase (NAGS) deficiency.⁵ NAGS deficiency is an extremely rare genetic disorder that presents shortly after birth. It results in hyperammonemia, and can be fatal if not rapidly detected and managed. Carglumic acid treats the hyperammonemia within three days, with a lowering of the ammonia level within 24 hours. In clinical trials, a small number of patients (n=23) received the drug from six months to 21 years; the majority of patients were able to maintain normal ammonia levels long-term with continued treatment. It is recommended that carglumic acid only be administered by physicians who have experience dealing with metabolic disorders. The starting dose is between 100 mg/kg/day and 250 mg/kg/day for treatment of acute hyperammonemia. Using other agents to lower the ammonia level during acute episodes is recommended. Dosing should be based on the ammonia level and the patient’s symptoms.

CK-2017357 has received orphan drug status for treating amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.⁶

Desirudin injection (Iprivask), a direct thrombin inhibitor, has been approved by the FDA for the prevention of DVT.⁷ In clinical trials, it was superior to enoxaparin and unfractionated heparin for preventing proximal DVT and prevention of major venous thromboembolic events following elective hip replacement surgery. Desirudin is administered as a fixed subcutaneous dose. It does not cause thrombocytopenia, is relatively short-acting, and is easy to monitor. Some of the adverse reactions in clinical trials were thrombosis, hypotension, lower-extremity edema, fever, decreased hemoglobin level, and hematuria.⁸ Also known as Revasc, this medication has been available in Europe for more than 10 years.

Doxepin tablets (Silenor) have been approved by the FDA for the treatment of short-term and chronic insomnia distinguished by difficulty with sleep maintenance in adults and elderly patients.⁹ Sleep maintenance includes difficulty staying asleep, waking up too much or too early, and not being able to fall back asleep. In clinical trials, adverse reactions were similar to placebo, there was a low-therapy discontinuation rate, and no evidence of amnesia, tolerance, or complex sleep behaviors such as sleep eating or sleep driving.¹⁰ It will be available in 3-mg and 6-mg tablets. It is not designated as a controlled substance.

GVAX pancreas vaccine has received orphan drug status as a potential treatment for pancreatic cancer.¹¹ It also is being investigated for other cancers, including those of the breast and for leukemias.

Ritonavir (Norvir) has been approved by the FDA in a new formulation, which is heat-stable and can be stored at room temperature rather than in the refrigerator.¹² The rate of drug absorption with the new formulation is different but does not require a dosage change.

Somatropin [rDNA origin] prefilled injection pen (Norditropin FlexPro) has been approved by the FDA to treat adults and children with growth hormone disorders.¹³ The pen has an audible click and does not require any reconstitution or cartridge loading. After initial use, the pen can be left at room temperature for up to three weeks without worry of drug degradation.

Pipeline

Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.¹⁴ It is an enzyme replacement therapy.

Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.¹⁵

Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.¹⁶

A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.¹⁷

Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.¹⁸ The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.

Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.

Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.

FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.

Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.

UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.

Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.

First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.

FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.

UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.

BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.

Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.

Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.

Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.

Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.

Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.

U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.

Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.

Issue

The Hospitalist - 2010(07)

Publications

Read more about Market Watch

Sections

Author(s)

Author(s)

New Drugs, Indications, Dosage Forms, and Approval Recommendations

Acetaminophen intravenous (Ofirmev) received a complete response letter in February from the FDA related to facility manufacturing deficiencies. The FDA did not cite any safety or efficacy issues and is not requiring any additional studies to be done prior to approval.¹ The third-party manufacturer has submitted its response to the FDA and is ready to resubmit their new drug application (NDA) for this agent. It is being investigated to treat fever and pain in adults and children.²

Ciprofloxacin dry powder inhaler (DPI) has received orphan drug status from the FDA for treating pulmonary infections in cystic fibrosis (CF) patients.^3,4 It is in clinical trials to determine if it can improve pulmonary function in CF patients with Pseudomonas aeruginosa infections.

Carglumic acid (Carbaglu) has been approved by the FDA to treat the metabolic disorder N-acetylglutamate synthetase (NAGS) deficiency.⁵ NAGS deficiency is an extremely rare genetic disorder that presents shortly after birth. It results in hyperammonemia, and can be fatal if not rapidly detected and managed. Carglumic acid treats the hyperammonemia within three days, with a lowering of the ammonia level within 24 hours. In clinical trials, a small number of patients (n=23) received the drug from six months to 21 years; the majority of patients were able to maintain normal ammonia levels long-term with continued treatment. It is recommended that carglumic acid only be administered by physicians who have experience dealing with metabolic disorders. The starting dose is between 100 mg/kg/day and 250 mg/kg/day for treatment of acute hyperammonemia. Using other agents to lower the ammonia level during acute episodes is recommended. Dosing should be based on the ammonia level and the patient’s symptoms.

CK-2017357 has received orphan drug status for treating amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.⁶

Desirudin injection (Iprivask), a direct thrombin inhibitor, has been approved by the FDA for the prevention of DVT.⁷ In clinical trials, it was superior to enoxaparin and unfractionated heparin for preventing proximal DVT and prevention of major venous thromboembolic events following elective hip replacement surgery. Desirudin is administered as a fixed subcutaneous dose. It does not cause thrombocytopenia, is relatively short-acting, and is easy to monitor. Some of the adverse reactions in clinical trials were thrombosis, hypotension, lower-extremity edema, fever, decreased hemoglobin level, and hematuria.⁸ Also known as Revasc, this medication has been available in Europe for more than 10 years.

Doxepin tablets (Silenor) have been approved by the FDA for the treatment of short-term and chronic insomnia distinguished by difficulty with sleep maintenance in adults and elderly patients.⁹ Sleep maintenance includes difficulty staying asleep, waking up too much or too early, and not being able to fall back asleep. In clinical trials, adverse reactions were similar to placebo, there was a low-therapy discontinuation rate, and no evidence of amnesia, tolerance, or complex sleep behaviors such as sleep eating or sleep driving.¹⁰ It will be available in 3-mg and 6-mg tablets. It is not designated as a controlled substance.

GVAX pancreas vaccine has received orphan drug status as a potential treatment for pancreatic cancer.¹¹ It also is being investigated for other cancers, including those of the breast and for leukemias.

Ritonavir (Norvir) has been approved by the FDA in a new formulation, which is heat-stable and can be stored at room temperature rather than in the refrigerator.¹² The rate of drug absorption with the new formulation is different but does not require a dosage change.

Somatropin [rDNA origin] prefilled injection pen (Norditropin FlexPro) has been approved by the FDA to treat adults and children with growth hormone disorders.¹³ The pen has an audible click and does not require any reconstitution or cartridge loading. After initial use, the pen can be left at room temperature for up to three weeks without worry of drug degradation.

Pipeline

Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.¹⁴ It is an enzyme replacement therapy.

Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.¹⁵

Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.¹⁶

A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.¹⁷

Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.¹⁸ The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.

Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.

Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.

FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.

Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.

UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.

Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.

First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.

FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.

UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.

BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.

Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.

Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.

Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.

Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.

Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.

U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.

Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.

New Drugs, Indications, Dosage Forms, and Approval Recommendations

Acetaminophen intravenous (Ofirmev) received a complete response letter in February from the FDA related to facility manufacturing deficiencies. The FDA did not cite any safety or efficacy issues and is not requiring any additional studies to be done prior to approval.¹ The third-party manufacturer has submitted its response to the FDA and is ready to resubmit their new drug application (NDA) for this agent. It is being investigated to treat fever and pain in adults and children.²

Ciprofloxacin dry powder inhaler (DPI) has received orphan drug status from the FDA for treating pulmonary infections in cystic fibrosis (CF) patients.^3,4 It is in clinical trials to determine if it can improve pulmonary function in CF patients with Pseudomonas aeruginosa infections.

Carglumic acid (Carbaglu) has been approved by the FDA to treat the metabolic disorder N-acetylglutamate synthetase (NAGS) deficiency.⁵ NAGS deficiency is an extremely rare genetic disorder that presents shortly after birth. It results in hyperammonemia, and can be fatal if not rapidly detected and managed. Carglumic acid treats the hyperammonemia within three days, with a lowering of the ammonia level within 24 hours. In clinical trials, a small number of patients (n=23) received the drug from six months to 21 years; the majority of patients were able to maintain normal ammonia levels long-term with continued treatment. It is recommended that carglumic acid only be administered by physicians who have experience dealing with metabolic disorders. The starting dose is between 100 mg/kg/day and 250 mg/kg/day for treatment of acute hyperammonemia. Using other agents to lower the ammonia level during acute episodes is recommended. Dosing should be based on the ammonia level and the patient’s symptoms.

CK-2017357 has received orphan drug status for treating amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.⁶

Desirudin injection (Iprivask), a direct thrombin inhibitor, has been approved by the FDA for the prevention of DVT.⁷ In clinical trials, it was superior to enoxaparin and unfractionated heparin for preventing proximal DVT and prevention of major venous thromboembolic events following elective hip replacement surgery. Desirudin is administered as a fixed subcutaneous dose. It does not cause thrombocytopenia, is relatively short-acting, and is easy to monitor. Some of the adverse reactions in clinical trials were thrombosis, hypotension, lower-extremity edema, fever, decreased hemoglobin level, and hematuria.⁸ Also known as Revasc, this medication has been available in Europe for more than 10 years.

Doxepin tablets (Silenor) have been approved by the FDA for the treatment of short-term and chronic insomnia distinguished by difficulty with sleep maintenance in adults and elderly patients.⁹ Sleep maintenance includes difficulty staying asleep, waking up too much or too early, and not being able to fall back asleep. In clinical trials, adverse reactions were similar to placebo, there was a low-therapy discontinuation rate, and no evidence of amnesia, tolerance, or complex sleep behaviors such as sleep eating or sleep driving.¹⁰ It will be available in 3-mg and 6-mg tablets. It is not designated as a controlled substance.

GVAX pancreas vaccine has received orphan drug status as a potential treatment for pancreatic cancer.¹¹ It also is being investigated for other cancers, including those of the breast and for leukemias.

Ritonavir (Norvir) has been approved by the FDA in a new formulation, which is heat-stable and can be stored at room temperature rather than in the refrigerator.¹² The rate of drug absorption with the new formulation is different but does not require a dosage change.

Somatropin [rDNA origin] prefilled injection pen (Norditropin FlexPro) has been approved by the FDA to treat adults and children with growth hormone disorders.¹³ The pen has an audible click and does not require any reconstitution or cartridge loading. After initial use, the pen can be left at room temperature for up to three weeks without worry of drug degradation.

Pipeline

Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.¹⁴ It is an enzyme replacement therapy.

Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.¹⁵

Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.¹⁶

A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.¹⁷

Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.¹⁸ The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.

Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.

Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.

FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.

Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.

UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.

Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.

First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.

FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.

UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.

BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.

Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.

Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.

Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.

Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.

Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.

U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.

Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.

Issue

The Hospitalist - 2010(07)

Issue

The Hospitalist - 2010(07)

Publications

Publications

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:30

Display Headline

Market Watch

Author(s)

New Generics

Imiquimod cream 5% (generic Aldara)1

Losartan tablets (generic Cozaar)2

Losartan/hydrochlorothiazide tablets (generic Hyzaar)2

New Drugs, Indications, Approval Recommendations

Olmesartan medoxomil (Benicar) has been approved by the FDA for treating hypertension in patients ages 6 to 16.3 It has been approved for treating hypertension in adults since 2002.

Late last year, the prescribing information for rasagiline (Azilect) was updated to remove restrictions related to dietary tyramine ingestion (known as the “cheese reaction”), and removal of restrictions related to concomitant use of sympathomimetic amines (e.g., phenylephrine, pseudoephedrine, ephedrine, etc.) when used at the recommended doses of 0.5 mg and 1 mg.4,5

Rifaximin (Xifaxin) has been approved by the FDA for treating hepatic encephalopathy.6 Twice-daily use of rifaximin 550 mg maintains remission from hepatic encephalopathy more effectively than placebo over a six-month period and significantly reduces the risk of hospitalization.7 In this study, more than 90% of patients also received lactulose. Rifaximin also has been approved by the FDA for treating travelers’ diarrhea.

Earlier this year, rosuvastatin (Crestor) became the first statin to garner FDA approval for primary prevention of cardiovascular disease.8 Patients who might benefit from primary prevention include men 50 years or older and women 60 years or older with a fasting LDL <130 mg/dL, a highly-sensitive C-reactive protein level of greater than 2 mg/L, a triglyceride level lower than 500 mg/dL, and no prior history of stroke, myocardial infarction, or coronary heart-disease risk.

Pipeline

Fingolimod (FTY720, Gilenia), a once-daily oral disease modifying therapy for the treatment of multiple sclerosis, has been granted a priority review by the FDA. 9 The New Drug Application (NDA) was accepted in December 2009, but a priority review decreases the standard 10-month review to six months. The timeframe, however, could be extended to evaluate a risk evaluation and mitigation strategy (REMS) program. This sphingosine 1-phosphate receptor (S1P-R) has been shown to significantly reduce both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.

Safety Information

Oral bisphosphonates: On March 11, the FDA posted information related to a possible connection between the use of bisphosphonates and the risk of developing atypical sub-trochanteric femur fractures.8 Two weeks later, a study and accompanying editorial described how there is no link between bisphosphonates and femur fractures.10,11 As of press time, the FDA had not commented on the study results.

Clopidogrel has received a boxed warning related to decreased effectiveness when administered to patients who are poor metabolizers of the agent.12 Approximately 2% to 14% of the U.S. population are poor metabolizers due to a variation in CYP2C19 liver enzyme function. The warning includes information for prescribers about genetic testing for patients to identify those who might be poor metabolizers of clopidogrel; the information should assist providers with decision-making on the most appropriate therapy.

Erythropoiesis-stimulating agents (ESAs): The FDA is requiring all ESAs to be prescribed and used under a REMS program to ensure their safe use.13 The measures were put in place after studies showed that ESA use can increase the risk of tumor growth and shorten survival in oncology patients. Only hospitals and healthcare professionals who enroll and complete specific training in the REMS program (known as ESA APPRISE Oncology) will be able to prescribe and dispense ESAs to healthcare professionals. All patients prescribed ESAs for any indication must receive a copy of the medication guide when the drug is dispensed. For prescribers using ESAs for noncancer indications (e.g., anemia related to HIV, chronic kidney disease patients, etc.), enrollment in the REMS program is not required; however, a medication guide must be given to patients when the drug is dispensed. For more information, visit www.esa-apprise.com/.

Ritonavir (Norvir) and saquinavir (Invirase) combination and cardiac effects: The FDA is evaluating preliminary data that indicate the combined use of ritonavir and saquinavir might lead to prolongation of the QT and PR interval of the electrocardiogram, and might lead to Torsades de Pointes or heart block.14 Any patients receiving both of these agents should be evaluated for such symptoms as lightheadedness, fainting, or arrhythmias. The risk of arrhythmias may be increased in patients with a history of QT interval prolongation.

Increased risk of muscle injury with high-dose simvastatin: The FDA has identified that the highest dose of simvastatin (80 mg) is associated with a greater risk of muscle injury, including rhabdomyolysis.15 The concern with simvastatin is as a single ingredient, and as part of combinations with ezetimibe or niacin. The FDA will publish a report when the review has been completed. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Fougera announces first generic approval of imiquimod cream 5% (Rx), equivalent to Aldara. Fougera website. Available at: http://www.fougera.com/news/release_detail.asp?id=1057. Accessed March 5, 2010.

Dane L. US court ruling restores Teva’s marketing exclusivity for generics of Merck & Co. hypertension drugs. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=A9C69CCA747746D2832D25A523C54E63&logRowId=353155. Accessed March 23, 2010.

FDA approves Benicar for the treatment of high blood pressure in children and adolescents aged 6-16. Available at: http://www.dsi.com/news/pdfs/FINAL_Benicar_Pediatric_Approval_Press_Release.pdf. Accessed March 23, 2010.

FDA approves newly revised prescribing information for Azilect reducing medication and food restriction. Teva website. Available at: http://www.tevaneuroscience.com/NewsContent.aspx?Ispreview=No&Type=News&Id=251&Status=Current. Accessed March 23, 2010.

Tilyou S. Tyramine-rich foods and rasagiline not always a bad mix. Pharmacy Practice News website. Available at: http://www.pharmacypracticenews.com/index.asp?section_id=50&show=dept&issue_id=618&article_id=14885. Accessed March 25, 2010.

Drew J. FDA approves Salix drug Xifaxan as treatment for hepatic encephalopathy. Triangle Business Journal website. Available at: http://triangle.bizjournals.com/triangle/stories/2010/03/22/daily41.html?t=printable. Accessed March 25, 2010.

Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081.

Peck P, Agus ZS. FDA okays statin for primary prevention. MedPage Today website. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18380. Accessed March 23, 2010.

Novartis oral multiple sclerosis development compound Gilenia (FTY720) granted US priority review status. Novartis website. Available at: http://www.novartis.com/newsroom/media-releases/en/2010/1386852.shtml. Accessed March 23, 2010.

Oral bisphosphonates: ongoing safety review of atypical subtrochanteric femur fractures. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm. Accessed March 24, 2010.

Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med. 2010 Mar 24.

Shane E. Evolving data about subtrochanteric fractures and bisphosphonates. N Engl J Med. 2010 Mar 24.

Dane L. FDA adds boxed warning to Plavix to advise of reduced effectiveness in some patients. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=7AD8DC1985644F1683D822FE7C1EC2B4&logRowId=355395. Accessed March 24, 2010.

Drug safety communication: erythropoiesis-stimulating agents (ESAs): Procrit, Epogen and Aranesp. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm. Accessed March 24, 2010.

Jefferson E. FDA Announces Possible Safety Concern for HIV Drug Combination Published February 23, 2010 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201552.htm. Accessed March 24, 2010.

Issue

The Hospitalist - 2010(06)

Publications

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generics

Imiquimod cream 5% (generic Aldara)1

Losartan tablets (generic Cozaar)2

Losartan/hydrochlorothiazide tablets (generic Hyzaar)2

New Drugs, Indications, Approval Recommendations

Olmesartan medoxomil (Benicar) has been approved by the FDA for treating hypertension in patients ages 6 to 16.3 It has been approved for treating hypertension in adults since 2002.

Late last year, the prescribing information for rasagiline (Azilect) was updated to remove restrictions related to dietary tyramine ingestion (known as the “cheese reaction”), and removal of restrictions related to concomitant use of sympathomimetic amines (e.g., phenylephrine, pseudoephedrine, ephedrine, etc.) when used at the recommended doses of 0.5 mg and 1 mg.4,5

Rifaximin (Xifaxin) has been approved by the FDA for treating hepatic encephalopathy.6 Twice-daily use of rifaximin 550 mg maintains remission from hepatic encephalopathy more effectively than placebo over a six-month period and significantly reduces the risk of hospitalization.7 In this study, more than 90% of patients also received lactulose. Rifaximin also has been approved by the FDA for treating travelers’ diarrhea.

Earlier this year, rosuvastatin (Crestor) became the first statin to garner FDA approval for primary prevention of cardiovascular disease.8 Patients who might benefit from primary prevention include men 50 years or older and women 60 years or older with a fasting LDL <130 mg/dL, a highly-sensitive C-reactive protein level of greater than 2 mg/L, a triglyceride level lower than 500 mg/dL, and no prior history of stroke, myocardial infarction, or coronary heart-disease risk.

Pipeline

Fingolimod (FTY720, Gilenia), a once-daily oral disease modifying therapy for the treatment of multiple sclerosis, has been granted a priority review by the FDA. 9 The New Drug Application (NDA) was accepted in December 2009, but a priority review decreases the standard 10-month review to six months. The timeframe, however, could be extended to evaluate a risk evaluation and mitigation strategy (REMS) program. This sphingosine 1-phosphate receptor (S1P-R) has been shown to significantly reduce both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.

Safety Information

Oral bisphosphonates: On March 11, the FDA posted information related to a possible connection between the use of bisphosphonates and the risk of developing atypical sub-trochanteric femur fractures.8 Two weeks later, a study and accompanying editorial described how there is no link between bisphosphonates and femur fractures.10,11 As of press time, the FDA had not commented on the study results.

Clopidogrel has received a boxed warning related to decreased effectiveness when administered to patients who are poor metabolizers of the agent.12 Approximately 2% to 14% of the U.S. population are poor metabolizers due to a variation in CYP2C19 liver enzyme function. The warning includes information for prescribers about genetic testing for patients to identify those who might be poor metabolizers of clopidogrel; the information should assist providers with decision-making on the most appropriate therapy.

Erythropoiesis-stimulating agents (ESAs): The FDA is requiring all ESAs to be prescribed and used under a REMS program to ensure their safe use.13 The measures were put in place after studies showed that ESA use can increase the risk of tumor growth and shorten survival in oncology patients. Only hospitals and healthcare professionals who enroll and complete specific training in the REMS program (known as ESA APPRISE Oncology) will be able to prescribe and dispense ESAs to healthcare professionals. All patients prescribed ESAs for any indication must receive a copy of the medication guide when the drug is dispensed. For prescribers using ESAs for noncancer indications (e.g., anemia related to HIV, chronic kidney disease patients, etc.), enrollment in the REMS program is not required; however, a medication guide must be given to patients when the drug is dispensed. For more information, visit www.esa-apprise.com/.

Ritonavir (Norvir) and saquinavir (Invirase) combination and cardiac effects: The FDA is evaluating preliminary data that indicate the combined use of ritonavir and saquinavir might lead to prolongation of the QT and PR interval of the electrocardiogram, and might lead to Torsades de Pointes or heart block.14 Any patients receiving both of these agents should be evaluated for such symptoms as lightheadedness, fainting, or arrhythmias. The risk of arrhythmias may be increased in patients with a history of QT interval prolongation.

Increased risk of muscle injury with high-dose simvastatin: The FDA has identified that the highest dose of simvastatin (80 mg) is associated with a greater risk of muscle injury, including rhabdomyolysis.15 The concern with simvastatin is as a single ingredient, and as part of combinations with ezetimibe or niacin. The FDA will publish a report when the review has been completed. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Fougera announces first generic approval of imiquimod cream 5% (Rx), equivalent to Aldara. Fougera website. Available at: http://www.fougera.com/news/release_detail.asp?id=1057. Accessed March 5, 2010.

Dane L. US court ruling restores Teva’s marketing exclusivity for generics of Merck & Co. hypertension drugs. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=A9C69CCA747746D2832D25A523C54E63&logRowId=353155. Accessed March 23, 2010.

FDA approves Benicar for the treatment of high blood pressure in children and adolescents aged 6-16. Available at: http://www.dsi.com/news/pdfs/FINAL_Benicar_Pediatric_Approval_Press_Release.pdf. Accessed March 23, 2010.

FDA approves newly revised prescribing information for Azilect reducing medication and food restriction. Teva website. Available at: http://www.tevaneuroscience.com/NewsContent.aspx?Ispreview=No&Type=News&Id=251&Status=Current. Accessed March 23, 2010.

Tilyou S. Tyramine-rich foods and rasagiline not always a bad mix. Pharmacy Practice News website. Available at: http://www.pharmacypracticenews.com/index.asp?section_id=50&show=dept&issue_id=618&article_id=14885. Accessed March 25, 2010.

Drew J. FDA approves Salix drug Xifaxan as treatment for hepatic encephalopathy. Triangle Business Journal website. Available at: http://triangle.bizjournals.com/triangle/stories/2010/03/22/daily41.html?t=printable. Accessed March 25, 2010.

Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081.

Peck P, Agus ZS. FDA okays statin for primary prevention. MedPage Today website. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18380. Accessed March 23, 2010.

Novartis oral multiple sclerosis development compound Gilenia (FTY720) granted US priority review status. Novartis website. Available at: http://www.novartis.com/newsroom/media-releases/en/2010/1386852.shtml. Accessed March 23, 2010.

Oral bisphosphonates: ongoing safety review of atypical subtrochanteric femur fractures. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm. Accessed March 24, 2010.

Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med. 2010 Mar 24.

Shane E. Evolving data about subtrochanteric fractures and bisphosphonates. N Engl J Med. 2010 Mar 24.

Dane L. FDA adds boxed warning to Plavix to advise of reduced effectiveness in some patients. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=7AD8DC1985644F1683D822FE7C1EC2B4&logRowId=355395. Accessed March 24, 2010.

Drug safety communication: erythropoiesis-stimulating agents (ESAs): Procrit, Epogen and Aranesp. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm. Accessed March 24, 2010.

Jefferson E. FDA Announces Possible Safety Concern for HIV Drug Combination Published February 23, 2010 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201552.htm. Accessed March 24, 2010.

New Generics

Imiquimod cream 5% (generic Aldara)1

Losartan tablets (generic Cozaar)2

Losartan/hydrochlorothiazide tablets (generic Hyzaar)2

New Drugs, Indications, Approval Recommendations

Olmesartan medoxomil (Benicar) has been approved by the FDA for treating hypertension in patients ages 6 to 16.3 It has been approved for treating hypertension in adults since 2002.

Late last year, the prescribing information for rasagiline (Azilect) was updated to remove restrictions related to dietary tyramine ingestion (known as the “cheese reaction”), and removal of restrictions related to concomitant use of sympathomimetic amines (e.g., phenylephrine, pseudoephedrine, ephedrine, etc.) when used at the recommended doses of 0.5 mg and 1 mg.4,5

Rifaximin (Xifaxin) has been approved by the FDA for treating hepatic encephalopathy.6 Twice-daily use of rifaximin 550 mg maintains remission from hepatic encephalopathy more effectively than placebo over a six-month period and significantly reduces the risk of hospitalization.7 In this study, more than 90% of patients also received lactulose. Rifaximin also has been approved by the FDA for treating travelers’ diarrhea.

Earlier this year, rosuvastatin (Crestor) became the first statin to garner FDA approval for primary prevention of cardiovascular disease.8 Patients who might benefit from primary prevention include men 50 years or older and women 60 years or older with a fasting LDL <130 mg/dL, a highly-sensitive C-reactive protein level of greater than 2 mg/L, a triglyceride level lower than 500 mg/dL, and no prior history of stroke, myocardial infarction, or coronary heart-disease risk.

Pipeline

Fingolimod (FTY720, Gilenia), a once-daily oral disease modifying therapy for the treatment of multiple sclerosis, has been granted a priority review by the FDA. 9 The New Drug Application (NDA) was accepted in December 2009, but a priority review decreases the standard 10-month review to six months. The timeframe, however, could be extended to evaluate a risk evaluation and mitigation strategy (REMS) program. This sphingosine 1-phosphate receptor (S1P-R) has been shown to significantly reduce both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.

Safety Information

Oral bisphosphonates: On March 11, the FDA posted information related to a possible connection between the use of bisphosphonates and the risk of developing atypical sub-trochanteric femur fractures.8 Two weeks later, a study and accompanying editorial described how there is no link between bisphosphonates and femur fractures.10,11 As of press time, the FDA had not commented on the study results.

Clopidogrel has received a boxed warning related to decreased effectiveness when administered to patients who are poor metabolizers of the agent.12 Approximately 2% to 14% of the U.S. population are poor metabolizers due to a variation in CYP2C19 liver enzyme function. The warning includes information for prescribers about genetic testing for patients to identify those who might be poor metabolizers of clopidogrel; the information should assist providers with decision-making on the most appropriate therapy.

Erythropoiesis-stimulating agents (ESAs): The FDA is requiring all ESAs to be prescribed and used under a REMS program to ensure their safe use.13 The measures were put in place after studies showed that ESA use can increase the risk of tumor growth and shorten survival in oncology patients. Only hospitals and healthcare professionals who enroll and complete specific training in the REMS program (known as ESA APPRISE Oncology) will be able to prescribe and dispense ESAs to healthcare professionals. All patients prescribed ESAs for any indication must receive a copy of the medication guide when the drug is dispensed. For prescribers using ESAs for noncancer indications (e.g., anemia related to HIV, chronic kidney disease patients, etc.), enrollment in the REMS program is not required; however, a medication guide must be given to patients when the drug is dispensed. For more information, visit www.esa-apprise.com/.

Ritonavir (Norvir) and saquinavir (Invirase) combination and cardiac effects: The FDA is evaluating preliminary data that indicate the combined use of ritonavir and saquinavir might lead to prolongation of the QT and PR interval of the electrocardiogram, and might lead to Torsades de Pointes or heart block.14 Any patients receiving both of these agents should be evaluated for such symptoms as lightheadedness, fainting, or arrhythmias. The risk of arrhythmias may be increased in patients with a history of QT interval prolongation.

Increased risk of muscle injury with high-dose simvastatin: The FDA has identified that the highest dose of simvastatin (80 mg) is associated with a greater risk of muscle injury, including rhabdomyolysis.15 The concern with simvastatin is as a single ingredient, and as part of combinations with ezetimibe or niacin. The FDA will publish a report when the review has been completed. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Fougera announces first generic approval of imiquimod cream 5% (Rx), equivalent to Aldara. Fougera website. Available at: http://www.fougera.com/news/release_detail.asp?id=1057. Accessed March 5, 2010.

Dane L. US court ruling restores Teva’s marketing exclusivity for generics of Merck & Co. hypertension drugs. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=A9C69CCA747746D2832D25A523C54E63&logRowId=353155. Accessed March 23, 2010.

FDA approves Benicar for the treatment of high blood pressure in children and adolescents aged 6-16. Available at: http://www.dsi.com/news/pdfs/FINAL_Benicar_Pediatric_Approval_Press_Release.pdf. Accessed March 23, 2010.

FDA approves newly revised prescribing information for Azilect reducing medication and food restriction. Teva website. Available at: http://www.tevaneuroscience.com/NewsContent.aspx?Ispreview=No&Type=News&Id=251&Status=Current. Accessed March 23, 2010.

Tilyou S. Tyramine-rich foods and rasagiline not always a bad mix. Pharmacy Practice News website. Available at: http://www.pharmacypracticenews.com/index.asp?section_id=50&show=dept&issue_id=618&article_id=14885. Accessed March 25, 2010.

Drew J. FDA approves Salix drug Xifaxan as treatment for hepatic encephalopathy. Triangle Business Journal website. Available at: http://triangle.bizjournals.com/triangle/stories/2010/03/22/daily41.html?t=printable. Accessed March 25, 2010.

Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081.

Peck P, Agus ZS. FDA okays statin for primary prevention. MedPage Today website. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18380. Accessed March 23, 2010.

Novartis oral multiple sclerosis development compound Gilenia (FTY720) granted US priority review status. Novartis website. Available at: http://www.novartis.com/newsroom/media-releases/en/2010/1386852.shtml. Accessed March 23, 2010.

Oral bisphosphonates: ongoing safety review of atypical subtrochanteric femur fractures. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm. Accessed March 24, 2010.

Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med. 2010 Mar 24.

Shane E. Evolving data about subtrochanteric fractures and bisphosphonates. N Engl J Med. 2010 Mar 24.

Dane L. FDA adds boxed warning to Plavix to advise of reduced effectiveness in some patients. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=7AD8DC1985644F1683D822FE7C1EC2B4&logRowId=355395. Accessed March 24, 2010.

Drug safety communication: erythropoiesis-stimulating agents (ESAs): Procrit, Epogen and Aranesp. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm. Accessed March 24, 2010.

Jefferson E. FDA Announces Possible Safety Concern for HIV Drug Combination Published February 23, 2010 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201552.htm. Accessed March 24, 2010.

Issue

The Hospitalist - 2010(06)

Issue

The Hospitalist - 2010(06)

Publications

Publications

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:31

Display Headline

Market Watch

Author(s)

New Generic

Perindopril erbumine tablets (generic Aceon)¹

New Drugs, Indications, Dosage Forms, and Approval Recommendations

Collagenase clostridium histolytica injection (Xiaflex) has been approved by the FDA for treating the hand disease Dupuytren’s contracture. The agent breaks down excessive collagen in the hand, allowing patients to straighten the arm and have proper use of their fingers. The agent is also being studied to treat Peyronie’s disease.²

Dalfampridine tablets (Ampyra) have been approved by the FDA to improve walking in patients with multiple sclerosis (MS).³ Seizures might occur in patients who exceed the recommended daily dose of 10 mg twice daily, or in patients with moderate to severe kidney disease. Therefore, caution is advised in these patients.

Iloperidone tablets (Fanapt) have been approved by the FDA for the acute treatment of schizophrenia in adults.⁴ An atypical antipsychotic, it is a mixed dopamine D2/serotonin 5HT2A receptor antagonist.

Lamotrigine extended-release tablets (Lamictal XR) have received a new FDA-approved indication for once-daily, add-on therapy for epilepsy in patients 13 years and older, with primary, generalized tonic-clonic seizures.⁵

Liraglutide (Victoza) has been approved by the FDA as a once-daily injection for the treatment of Type 2 diabetes mellitus.⁶ Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is similar to exenatide. There is a label warning related to thyroid tumors that occurred in rats and mice. It is unclear whether medullary thyroid cancer will occur in adults; therefore, the agent should not be used in patients who already have this cancer or those with a family history of thyroid cancer.

Trazodone extended-release tablets (Oleptro) have been approved by the FDA for treating major depressive disorder in adults.⁷ This product is formulated using Labopharm’s proprietary Contramid long-acting drug delivery system. The product will be available later this year.

Safety Information

Didanosine (Videx/Videx EC) has undergone a label change in the warning and precautions sections related to the rare but serious complication of noncirrhotic portal hypertension. The label change was added because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices. A number of well-documented, postmarketing reports of this reaction were made following exclusion of other portal hypertension causes.⁸

Long-acting beta-agonists (LABAs), formoterol (Foradil), and salmeterol (Sereven) are required to have a risk management strategy (REMS) and a revised medication guide written specifically for patients. The goal is to educate patients about the appropriate use of LABAs. There also is a plan to educate healthcare professionals about the appropriate use of LABAs.^9,10 This update is due to continued analysis of studies that show increased risk of severe asthma exacerbations, which lead to hospitalizations in adult and pediatric patients, including deaths in some LABA-utilizing patients. To safely use LABAs, the following need to be considered:

Single-ingredient LABAs should not be used as monotherapy; they should only be used in combination with an asthma controller;

LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controllers;

Use an LABA for the shortest duration required to achieve asthma control and discontinue it, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller; and

Use a combination product containing both an inhaled corticosteroid and an LABA to enhance adherence in pediatric and adolescent patients who require both of these classes to manage their asthma.

Olanzapine (Zyprexa) has undergone a label change related to its indications for use in adolescents ages ^13-17 for treating schizophrenia and bipolar I disorder (manic or mixed episodes).¹¹ The new label asks providers to consider alternative treatments in this patient population due to the increased potential for weight gain and hyperlipidemia. Additionally, the effectiveness and safety of this agent have not been determined in patients under 13.

Sibutramine (Meridia), marketed for weight loss, continues to be evaluated for safety.¹² A recent review found it poses an increased risk of heart attack and stroke in patients with a history of cardiovascular disease. Although the product label already had a warning related to use in patients with cardiovascular disease, the manufacturer has added a new contraindication to the sibutramine label for patients with cardiovascular disease and a history of: 1) coronary artery disease; 2) stroke or transient ischemic attack; 3) arrhythmias; 4) congestive heart failure; 5) peripheral arterial disease; and/or 6) uncontrolled hypertension (e.g., >145/90 mmHg). Providers should monitor blood pressure and heart rate regularly. If there is an unremitting increase in blood pressure and/or heart rate, sibutramine should be discontinued. Sibutramine should also be stopped in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment.¹³TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Lupin receives US FDA approval for Perindopril erbumine tablets. Lupin Web site. Available at: http://www.lupinworld.com/28jan10.htm. Accessed Feb. 22, 2010.

US FDA approves Auxilium drug for hand disease. Reuters Web site. Available at: http://www.reuters.com/article/idUSN0211921420100203. Accessed Feb. 22, 2010.

Petrochko C. MS walking drug gets FDA nod. MedPage Today Web site. Available at: http://www.medpagetoday.com/Neurology/MultipleSclerosis/18112. Accessed Feb. 22, 2010.

Fanapt available for acute schizophrenia. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fanapt-available-for-acute-schizophrenia/article/160985/. Accessed Feb. 22, 2010.

FDA approves once-a-day Lamictal XR as add-on epilepsy therapy for primary generalized tonic-clonic seizures. Available at: http://www.medicalnewstoday.com/articles/177796.php. Accessed Feb. 22, 2010.

FDA approves new treatment for Type 2 diabetes. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed Feb. 22, 2010.

Labopharm receives FDA approval for Oleptro. PR Newswire Web site. Available at: http://www.prnewswire.com/news-releases/labopharm-receives-fda-approval-for-oleptrotm-83429037.html. Accessed Feb. 22, 2010.

Videx/Videx EC (didanosine): Labeling revision—risk of non-cirrhotic portal hypertension. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm. Accessed Feb. 22, 2010.

Long-acting beta-agonists (LABAs): new safe use requirements. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm. Accessed Feb. 22, 2010.

Gever J. FDA says LABA asthma drugs not safe for solo use. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18552. Accessed Feb. 22, 2010.

Zyprexa (olanzapine): use in adolescents. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm. Accessed Feb. 22, 2010.

Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed Feb. 21, 2010.

Petrochko C. FDA adds cardio warnings to weight-loss drug. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18088?. Accessed Feb. 22, 2010.

Issue

The Hospitalist - 2010(05)

Publications

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generic

Perindopril erbumine tablets (generic Aceon)¹

New Drugs, Indications, Dosage Forms, and Approval Recommendations

Collagenase clostridium histolytica injection (Xiaflex) has been approved by the FDA for treating the hand disease Dupuytren’s contracture. The agent breaks down excessive collagen in the hand, allowing patients to straighten the arm and have proper use of their fingers. The agent is also being studied to treat Peyronie’s disease.²

Dalfampridine tablets (Ampyra) have been approved by the FDA to improve walking in patients with multiple sclerosis (MS).³ Seizures might occur in patients who exceed the recommended daily dose of 10 mg twice daily, or in patients with moderate to severe kidney disease. Therefore, caution is advised in these patients.

Iloperidone tablets (Fanapt) have been approved by the FDA for the acute treatment of schizophrenia in adults.⁴ An atypical antipsychotic, it is a mixed dopamine D2/serotonin 5HT2A receptor antagonist.

Lamotrigine extended-release tablets (Lamictal XR) have received a new FDA-approved indication for once-daily, add-on therapy for epilepsy in patients 13 years and older, with primary, generalized tonic-clonic seizures.⁵

Liraglutide (Victoza) has been approved by the FDA as a once-daily injection for the treatment of Type 2 diabetes mellitus.⁶ Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is similar to exenatide. There is a label warning related to thyroid tumors that occurred in rats and mice. It is unclear whether medullary thyroid cancer will occur in adults; therefore, the agent should not be used in patients who already have this cancer or those with a family history of thyroid cancer.

Trazodone extended-release tablets (Oleptro) have been approved by the FDA for treating major depressive disorder in adults.⁷ This product is formulated using Labopharm’s proprietary Contramid long-acting drug delivery system. The product will be available later this year.

Safety Information

Didanosine (Videx/Videx EC) has undergone a label change in the warning and precautions sections related to the rare but serious complication of noncirrhotic portal hypertension. The label change was added because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices. A number of well-documented, postmarketing reports of this reaction were made following exclusion of other portal hypertension causes.⁸

Long-acting beta-agonists (LABAs), formoterol (Foradil), and salmeterol (Sereven) are required to have a risk management strategy (REMS) and a revised medication guide written specifically for patients. The goal is to educate patients about the appropriate use of LABAs. There also is a plan to educate healthcare professionals about the appropriate use of LABAs.^9,10 This update is due to continued analysis of studies that show increased risk of severe asthma exacerbations, which lead to hospitalizations in adult and pediatric patients, including deaths in some LABA-utilizing patients. To safely use LABAs, the following need to be considered:

Single-ingredient LABAs should not be used as monotherapy; they should only be used in combination with an asthma controller;

LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controllers;

Use an LABA for the shortest duration required to achieve asthma control and discontinue it, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller; and

Use a combination product containing both an inhaled corticosteroid and an LABA to enhance adherence in pediatric and adolescent patients who require both of these classes to manage their asthma.

Olanzapine (Zyprexa) has undergone a label change related to its indications for use in adolescents ages ^13-17 for treating schizophrenia and bipolar I disorder (manic or mixed episodes).¹¹ The new label asks providers to consider alternative treatments in this patient population due to the increased potential for weight gain and hyperlipidemia. Additionally, the effectiveness and safety of this agent have not been determined in patients under 13.

Sibutramine (Meridia), marketed for weight loss, continues to be evaluated for safety.¹² A recent review found it poses an increased risk of heart attack and stroke in patients with a history of cardiovascular disease. Although the product label already had a warning related to use in patients with cardiovascular disease, the manufacturer has added a new contraindication to the sibutramine label for patients with cardiovascular disease and a history of: 1) coronary artery disease; 2) stroke or transient ischemic attack; 3) arrhythmias; 4) congestive heart failure; 5) peripheral arterial disease; and/or 6) uncontrolled hypertension (e.g., >145/90 mmHg). Providers should monitor blood pressure and heart rate regularly. If there is an unremitting increase in blood pressure and/or heart rate, sibutramine should be discontinued. Sibutramine should also be stopped in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment.¹³TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Lupin receives US FDA approval for Perindopril erbumine tablets. Lupin Web site. Available at: http://www.lupinworld.com/28jan10.htm. Accessed Feb. 22, 2010.

US FDA approves Auxilium drug for hand disease. Reuters Web site. Available at: http://www.reuters.com/article/idUSN0211921420100203. Accessed Feb. 22, 2010.

Petrochko C. MS walking drug gets FDA nod. MedPage Today Web site. Available at: http://www.medpagetoday.com/Neurology/MultipleSclerosis/18112. Accessed Feb. 22, 2010.

Fanapt available for acute schizophrenia. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fanapt-available-for-acute-schizophrenia/article/160985/. Accessed Feb. 22, 2010.

FDA approves once-a-day Lamictal XR as add-on epilepsy therapy for primary generalized tonic-clonic seizures. Available at: http://www.medicalnewstoday.com/articles/177796.php. Accessed Feb. 22, 2010.

FDA approves new treatment for Type 2 diabetes. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed Feb. 22, 2010.

Labopharm receives FDA approval for Oleptro. PR Newswire Web site. Available at: http://www.prnewswire.com/news-releases/labopharm-receives-fda-approval-for-oleptrotm-83429037.html. Accessed Feb. 22, 2010.

Videx/Videx EC (didanosine): Labeling revision—risk of non-cirrhotic portal hypertension. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm. Accessed Feb. 22, 2010.

Long-acting beta-agonists (LABAs): new safe use requirements. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm. Accessed Feb. 22, 2010.

Gever J. FDA says LABA asthma drugs not safe for solo use. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18552. Accessed Feb. 22, 2010.

Zyprexa (olanzapine): use in adolescents. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm. Accessed Feb. 22, 2010.

Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed Feb. 21, 2010.

Petrochko C. FDA adds cardio warnings to weight-loss drug. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18088?. Accessed Feb. 22, 2010.

New Generic

Perindopril erbumine tablets (generic Aceon)¹

New Drugs, Indications, Dosage Forms, and Approval Recommendations

Collagenase clostridium histolytica injection (Xiaflex) has been approved by the FDA for treating the hand disease Dupuytren’s contracture. The agent breaks down excessive collagen in the hand, allowing patients to straighten the arm and have proper use of their fingers. The agent is also being studied to treat Peyronie’s disease.²

Dalfampridine tablets (Ampyra) have been approved by the FDA to improve walking in patients with multiple sclerosis (MS).³ Seizures might occur in patients who exceed the recommended daily dose of 10 mg twice daily, or in patients with moderate to severe kidney disease. Therefore, caution is advised in these patients.

Iloperidone tablets (Fanapt) have been approved by the FDA for the acute treatment of schizophrenia in adults.⁴ An atypical antipsychotic, it is a mixed dopamine D2/serotonin 5HT2A receptor antagonist.

Lamotrigine extended-release tablets (Lamictal XR) have received a new FDA-approved indication for once-daily, add-on therapy for epilepsy in patients 13 years and older, with primary, generalized tonic-clonic seizures.⁵

Liraglutide (Victoza) has been approved by the FDA as a once-daily injection for the treatment of Type 2 diabetes mellitus.⁶ Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is similar to exenatide. There is a label warning related to thyroid tumors that occurred in rats and mice. It is unclear whether medullary thyroid cancer will occur in adults; therefore, the agent should not be used in patients who already have this cancer or those with a family history of thyroid cancer.

Trazodone extended-release tablets (Oleptro) have been approved by the FDA for treating major depressive disorder in adults.⁷ This product is formulated using Labopharm’s proprietary Contramid long-acting drug delivery system. The product will be available later this year.

Safety Information

Didanosine (Videx/Videx EC) has undergone a label change in the warning and precautions sections related to the rare but serious complication of noncirrhotic portal hypertension. The label change was added because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices. A number of well-documented, postmarketing reports of this reaction were made following exclusion of other portal hypertension causes.⁸

Long-acting beta-agonists (LABAs), formoterol (Foradil), and salmeterol (Sereven) are required to have a risk management strategy (REMS) and a revised medication guide written specifically for patients. The goal is to educate patients about the appropriate use of LABAs. There also is a plan to educate healthcare professionals about the appropriate use of LABAs.^9,10 This update is due to continued analysis of studies that show increased risk of severe asthma exacerbations, which lead to hospitalizations in adult and pediatric patients, including deaths in some LABA-utilizing patients. To safely use LABAs, the following need to be considered:

Single-ingredient LABAs should not be used as monotherapy; they should only be used in combination with an asthma controller;

LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controllers;

Use an LABA for the shortest duration required to achieve asthma control and discontinue it, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller; and

Use a combination product containing both an inhaled corticosteroid and an LABA to enhance adherence in pediatric and adolescent patients who require both of these classes to manage their asthma.

Olanzapine (Zyprexa) has undergone a label change related to its indications for use in adolescents ages ^13-17 for treating schizophrenia and bipolar I disorder (manic or mixed episodes).¹¹ The new label asks providers to consider alternative treatments in this patient population due to the increased potential for weight gain and hyperlipidemia. Additionally, the effectiveness and safety of this agent have not been determined in patients under 13.

Sibutramine (Meridia), marketed for weight loss, continues to be evaluated for safety.¹² A recent review found it poses an increased risk of heart attack and stroke in patients with a history of cardiovascular disease. Although the product label already had a warning related to use in patients with cardiovascular disease, the manufacturer has added a new contraindication to the sibutramine label for patients with cardiovascular disease and a history of: 1) coronary artery disease; 2) stroke or transient ischemic attack; 3) arrhythmias; 4) congestive heart failure; 5) peripheral arterial disease; and/or 6) uncontrolled hypertension (e.g., >145/90 mmHg). Providers should monitor blood pressure and heart rate regularly. If there is an unremitting increase in blood pressure and/or heart rate, sibutramine should be discontinued. Sibutramine should also be stopped in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment.¹³TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Lupin receives US FDA approval for Perindopril erbumine tablets. Lupin Web site. Available at: http://www.lupinworld.com/28jan10.htm. Accessed Feb. 22, 2010.

US FDA approves Auxilium drug for hand disease. Reuters Web site. Available at: http://www.reuters.com/article/idUSN0211921420100203. Accessed Feb. 22, 2010.

Petrochko C. MS walking drug gets FDA nod. MedPage Today Web site. Available at: http://www.medpagetoday.com/Neurology/MultipleSclerosis/18112. Accessed Feb. 22, 2010.

Fanapt available for acute schizophrenia. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fanapt-available-for-acute-schizophrenia/article/160985/. Accessed Feb. 22, 2010.

FDA approves once-a-day Lamictal XR as add-on epilepsy therapy for primary generalized tonic-clonic seizures. Available at: http://www.medicalnewstoday.com/articles/177796.php. Accessed Feb. 22, 2010.

FDA approves new treatment for Type 2 diabetes. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed Feb. 22, 2010.

Labopharm receives FDA approval for Oleptro. PR Newswire Web site. Available at: http://www.prnewswire.com/news-releases/labopharm-receives-fda-approval-for-oleptrotm-83429037.html. Accessed Feb. 22, 2010.

Videx/Videx EC (didanosine): Labeling revision—risk of non-cirrhotic portal hypertension. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm. Accessed Feb. 22, 2010.

Long-acting beta-agonists (LABAs): new safe use requirements. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm. Accessed Feb. 22, 2010.

Gever J. FDA says LABA asthma drugs not safe for solo use. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18552. Accessed Feb. 22, 2010.

Zyprexa (olanzapine): use in adolescents. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm. Accessed Feb. 22, 2010.

Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed Feb. 21, 2010.

Petrochko C. FDA adds cardio warnings to weight-loss drug. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18088?. Accessed Feb. 22, 2010.

Issue

The Hospitalist - 2010(05)

Issue

The Hospitalist - 2010(05)

Publications

Publications

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:31

Display Headline

Market Watch

Author(s)

Pipeline Drugs

Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.

Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.

FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5

Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.

Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.

Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.

Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.

FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.

FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.

Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.

Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.

Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.

Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Issue

The Hospitalist - 2010(04)

Publications

Topics

Read more about Market Watch

Sections

Author(s)

Author(s)

Pipeline Drugs

Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.

Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.

FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5

Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.

Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.

Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.

Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.

FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.

FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.

Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.

Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.

Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.

Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Pipeline Drugs

Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.

Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.

FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5

Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.

Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.

Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.

Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.

FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.

FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.

Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.

Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.

Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.

Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Issue

The Hospitalist - 2010(04)

Issue

The Hospitalist - 2010(04)

Publications

Publications

Topics

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:31

Display Headline

Market Watch

Author(s)

New Generics

Donepezil orally disintegrating tablets (generic Aricept ODT)1

Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.

New Drugs, Indications, and Dosage Forms

Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3

Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4

Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.

Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7

Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.

Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.

Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10

Pipeline

Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.

Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.

Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.

Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.

A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17

The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18

Safety Information

Pay attention to two agents manufactured by AstraZeneca: Dexlansoprazole (Kapidex), a new formulation of the proton-pump inhibitor lansoprazole, and bicalutamide (Casodex), which is used in combination with a hormone treatment for prostate cancer, have had medication mixups. The agent names look alike and sound alike when written and verbalized. Both written and verbal prescriptions have been dispensed in error. Bicalutamide is available as 50-mg tablets; dexlansoprazole is available as 30-mg and 60-mg capsules. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Walsh S. FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease. U.S. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm194173.htm. Accessed Dec. 28, 2009.

Amenal Receives FDA Approval For Nizatidine Oral Solution, the First Oral Solution for Axid in the Market. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/173591.php. Accessed Dec. 28, 2009.

Clonidine ER Suspension and Clonidine ER Tablets approved. Monthly Prescribing Reference Web site. Available at: www.empr.com/clonidine-er-suspension-and-clonidine-er-tablets-approved/article/159148/. Accessed Dec. 28, 2009.

FDA Approves Mcg Dose of Vagifem For the Treatment of Atrophic Vaginitis Due to Menopause. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/172804.php. Accessed Dec. 28, 2009.

Todoruk M. Eli Lilly’s Zyprexa approved in US for adolescents. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B5699B38AADB46AF85E7B34F508DB943&logRowId=340534. Accessed Dec. 28, 2009.

Dennis M. FDA approves Eli Lilly’s long-acting Zyprexa injection. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=30C504823E42425FA0C3B9BB8490D5AA&logRowId=341775. Accessed Dec. 28, 2009.

Gever J. FDA Approves Long-Acting Olanzapine. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17539. Accessed Dec. 28, 2009.

Dennis M. FDA approves AstraZeneca’s Seroquel XR as add-on therapy; requires more data as monotherapy. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=0530A906ABCB44B5A32EC05E148E0220&logRowId=340531. Accessed Dec. 28, 2009.

Petrochko C. FDA Approves IV Sildenafil for Hypertension. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17296. Accessed Dec. 28, 2009.

FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations. Pfizer Web site. Available at: mediaroom.pfizer.com/portal/site/pfizer/?ndmViewId=news_view&newsId=20091217006384&newsLang=en. Accessed Dec. 28, 2009.

Leuty R. Gilead wins panel OK for cystic fibrosis drug. San Francisco Business Times Web site. Available at: sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/12/07/daily59.html?surround=etf&ana=e_article. Accessed Dec. 28, 2009.

GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib. GlaxoSmithKline Web site. Available at: www.gsk.com/media/pressreleases/2009/2009_pressrelease_10141.htm. Accessed Dec. 29, 2009.

Todoruk M. EU panel issues positive opinion for Amgen’s Prolia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=A9F30DD044A14893899DF7D880FB8AB0&logRowId=342650. Accessed Dec. 29, 2009.

Walker EP. FDA Panel Backs Denosumab for Osteoporosis, But Not Osteopenia. MedPage Web site. Available at: www.medpagetoday.com/Endocrinology/Osteoporosis/15530. Accessed Dec. 29, 2009.

Phase 3 study of ocrelizumab for rheumatoid arthritis (RA). Monthly Prescribing Reference Web site. Available at: www.empr.com/phase-3-study-of-ocrelizumab-for-rheumatoid-arthritis-ra/article/159474/. Accessed Dec. 29, 2009.

Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE. Bayer Web site. Available at: www.bayer.com/en/News-Detail.aspx?id=12554. Accessed Dec. 20, 2009.

Todoruk M. Bayer, Johnson & Johnson provide update on Xarelto complete response to FDA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8F8AEC62E7DB46C3809C1E77A8384F30&logRowId=340535. Accessed Dec. 29, 2009.

O’Riordan M. FDA advisory panel votes in favor of broadened rosuvastatin indication. TheHeart.org Web site. Available at: www.theheart.org/article/1035155/print.do. Accessed Dec. 29, 2009.

Kapidex-Casodex confusion. Institute for Safe Medication Practices Web site. Available at: www.ismp.org/newsletters/ambulatory/archives/200907_1.asp. Accessed Dec. 28, 2009.

Issue

The Hospitalist - 2010(03)

Publications

Topics

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generics

Donepezil orally disintegrating tablets (generic Aricept ODT)1

Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.

New Drugs, Indications, and Dosage Forms

Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3

Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4

Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.

Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7

Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.

Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.

Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10

Pipeline

Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.

Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.

Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.

Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.

A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17

The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18

Safety Information

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Walsh S. FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease. U.S. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm194173.htm. Accessed Dec. 28, 2009.

Amenal Receives FDA Approval For Nizatidine Oral Solution, the First Oral Solution for Axid in the Market. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/173591.php. Accessed Dec. 28, 2009.

Clonidine ER Suspension and Clonidine ER Tablets approved. Monthly Prescribing Reference Web site. Available at: www.empr.com/clonidine-er-suspension-and-clonidine-er-tablets-approved/article/159148/. Accessed Dec. 28, 2009.

FDA Approves Mcg Dose of Vagifem For the Treatment of Atrophic Vaginitis Due to Menopause. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/172804.php. Accessed Dec. 28, 2009.

Todoruk M. Eli Lilly’s Zyprexa approved in US for adolescents. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B5699B38AADB46AF85E7B34F508DB943&logRowId=340534. Accessed Dec. 28, 2009.

Dennis M. FDA approves Eli Lilly’s long-acting Zyprexa injection. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=30C504823E42425FA0C3B9BB8490D5AA&logRowId=341775. Accessed Dec. 28, 2009.

Gever J. FDA Approves Long-Acting Olanzapine. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17539. Accessed Dec. 28, 2009.

Dennis M. FDA approves AstraZeneca’s Seroquel XR as add-on therapy; requires more data as monotherapy. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=0530A906ABCB44B5A32EC05E148E0220&logRowId=340531. Accessed Dec. 28, 2009.

Petrochko C. FDA Approves IV Sildenafil for Hypertension. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17296. Accessed Dec. 28, 2009.

FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations. Pfizer Web site. Available at: mediaroom.pfizer.com/portal/site/pfizer/?ndmViewId=news_view&newsId=20091217006384&newsLang=en. Accessed Dec. 28, 2009.

Leuty R. Gilead wins panel OK for cystic fibrosis drug. San Francisco Business Times Web site. Available at: sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/12/07/daily59.html?surround=etf&ana=e_article. Accessed Dec. 28, 2009.

GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib. GlaxoSmithKline Web site. Available at: www.gsk.com/media/pressreleases/2009/2009_pressrelease_10141.htm. Accessed Dec. 29, 2009.

Todoruk M. EU panel issues positive opinion for Amgen’s Prolia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=A9F30DD044A14893899DF7D880FB8AB0&logRowId=342650. Accessed Dec. 29, 2009.

Walker EP. FDA Panel Backs Denosumab for Osteoporosis, But Not Osteopenia. MedPage Web site. Available at: www.medpagetoday.com/Endocrinology/Osteoporosis/15530. Accessed Dec. 29, 2009.

Phase 3 study of ocrelizumab for rheumatoid arthritis (RA). Monthly Prescribing Reference Web site. Available at: www.empr.com/phase-3-study-of-ocrelizumab-for-rheumatoid-arthritis-ra/article/159474/. Accessed Dec. 29, 2009.

Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE. Bayer Web site. Available at: www.bayer.com/en/News-Detail.aspx?id=12554. Accessed Dec. 20, 2009.

Todoruk M. Bayer, Johnson & Johnson provide update on Xarelto complete response to FDA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8F8AEC62E7DB46C3809C1E77A8384F30&logRowId=340535. Accessed Dec. 29, 2009.

O’Riordan M. FDA advisory panel votes in favor of broadened rosuvastatin indication. TheHeart.org Web site. Available at: www.theheart.org/article/1035155/print.do. Accessed Dec. 29, 2009.

Kapidex-Casodex confusion. Institute for Safe Medication Practices Web site. Available at: www.ismp.org/newsletters/ambulatory/archives/200907_1.asp. Accessed Dec. 28, 2009.

New Generics

Donepezil orally disintegrating tablets (generic Aricept ODT)1

Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.

New Drugs, Indications, and Dosage Forms

Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3

Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4

Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.

Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7

Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.

Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.

Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10

Pipeline

Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.

Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.

Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.

Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.

A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17

The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18

Safety Information

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Walsh S. FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease. U.S. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm194173.htm. Accessed Dec. 28, 2009.

Amenal Receives FDA Approval For Nizatidine Oral Solution, the First Oral Solution for Axid in the Market. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/173591.php. Accessed Dec. 28, 2009.

Clonidine ER Suspension and Clonidine ER Tablets approved. Monthly Prescribing Reference Web site. Available at: www.empr.com/clonidine-er-suspension-and-clonidine-er-tablets-approved/article/159148/. Accessed Dec. 28, 2009.

FDA Approves Mcg Dose of Vagifem For the Treatment of Atrophic Vaginitis Due to Menopause. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/172804.php. Accessed Dec. 28, 2009.

Todoruk M. Eli Lilly’s Zyprexa approved in US for adolescents. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B5699B38AADB46AF85E7B34F508DB943&logRowId=340534. Accessed Dec. 28, 2009.

Dennis M. FDA approves Eli Lilly’s long-acting Zyprexa injection. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=30C504823E42425FA0C3B9BB8490D5AA&logRowId=341775. Accessed Dec. 28, 2009.

Gever J. FDA Approves Long-Acting Olanzapine. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17539. Accessed Dec. 28, 2009.

Dennis M. FDA approves AstraZeneca’s Seroquel XR as add-on therapy; requires more data as monotherapy. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=0530A906ABCB44B5A32EC05E148E0220&logRowId=340531. Accessed Dec. 28, 2009.

Petrochko C. FDA Approves IV Sildenafil for Hypertension. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17296. Accessed Dec. 28, 2009.

FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations. Pfizer Web site. Available at: mediaroom.pfizer.com/portal/site/pfizer/?ndmViewId=news_view&newsId=20091217006384&newsLang=en. Accessed Dec. 28, 2009.

Leuty R. Gilead wins panel OK for cystic fibrosis drug. San Francisco Business Times Web site. Available at: sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/12/07/daily59.html?surround=etf&ana=e_article. Accessed Dec. 28, 2009.

GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib. GlaxoSmithKline Web site. Available at: www.gsk.com/media/pressreleases/2009/2009_pressrelease_10141.htm. Accessed Dec. 29, 2009.

Todoruk M. EU panel issues positive opinion for Amgen’s Prolia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=A9F30DD044A14893899DF7D880FB8AB0&logRowId=342650. Accessed Dec. 29, 2009.

Walker EP. FDA Panel Backs Denosumab for Osteoporosis, But Not Osteopenia. MedPage Web site. Available at: www.medpagetoday.com/Endocrinology/Osteoporosis/15530. Accessed Dec. 29, 2009.

Phase 3 study of ocrelizumab for rheumatoid arthritis (RA). Monthly Prescribing Reference Web site. Available at: www.empr.com/phase-3-study-of-ocrelizumab-for-rheumatoid-arthritis-ra/article/159474/. Accessed Dec. 29, 2009.

Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE. Bayer Web site. Available at: www.bayer.com/en/News-Detail.aspx?id=12554. Accessed Dec. 20, 2009.

Todoruk M. Bayer, Johnson & Johnson provide update on Xarelto complete response to FDA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8F8AEC62E7DB46C3809C1E77A8384F30&logRowId=340535. Accessed Dec. 29, 2009.

O’Riordan M. FDA advisory panel votes in favor of broadened rosuvastatin indication. TheHeart.org Web site. Available at: www.theheart.org/article/1035155/print.do. Accessed Dec. 29, 2009.

Kapidex-Casodex confusion. Institute for Safe Medication Practices Web site. Available at: www.ismp.org/newsletters/ambulatory/archives/200907_1.asp. Accessed Dec. 28, 2009.

Issue

The Hospitalist - 2010(03)

Issue

The Hospitalist - 2010(03)

Publications

Publications

Topics

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:32

Display Headline

Market Watch

Author(s)

New Generics

Fentanyl citrate troche/lozenge (generic Actiq) transmucosal lollipop1,2

Perindopril erbumine (generic Aceon) tablets3

New Drugs, Indications, Label Changes, and Dosage Forms

Capsaicin 8% patch (Qutenza) has been approved by the U.S. Food and Drug Administration (FDA) as a prescription medication to treat pain associated with post-herpetic neuralgia.4 The patch is a higher concentration than over-the-counter (OTC) products. The most common side effects in clinical trials were pain, swelling, itching, redness, and bumps at the application site, as well as blood pressure increases.5 Patch placement requires the use of a topical anesthetic and additional pain relief (ice or opioid pain relievers). Therefore, patch placement must be performed by a healthcare professional. Once the patch is applied, the patient must be observed for at least an hour, as there could be a significant increase in blood pressure.

Diclofenac sodium topical (Pennsaid) has been approved by the FDA as a topical treatment to manage knee osteoarthritis.6 The transdermal carrier dimethylsulfoxide (DMSO) is utilized to deliver active diclofenac sodium through the skin to the pain site.7

Exenatide injection (Byetta) has been approved by the FDA as monotherapy for treating patients with Type 2 diabetes mellitus, along with diet and exercise.8

Human papilloma virus (HPV) vaccine (Gardasil) has been approved by the FDA for preventing condyloma acuminata due to HPV types 6 and 11 in males ages 9 to 26.9 The makers hope that this vaccine will decrease the need to treat genital warts. Clinical studies showed that in males not infected with HPV at the beginning of the study, the vaccine was close to 90% effective in preventing genital warts caused by infection of HPV types 6 and 11. The manufacturer plans to obtain additional safety and effectiveness information in this patient population.

Lansoprazole 24HR (Prevacid OTC) 15-mg delayed-release capsules are available for treating frequent heartburn.10 The capsules will be available by prescription in both the 15-mg and 30-mg dosage strengths.

Metoclopramide HCl orally disintegrating tablet (Metozolv ODT) has been approved by the FDA for treating both acute and recurrent diabetic gastroparesis and for the short-term management (four to 12 weeks) of adults with documented symptomatic gastroesophageal reflux disease who do not respond to conventional therapy.11

Peramivir intravenous will be made available by the Centers for Disease Control (CDC) as an emergency treatment for children and adult patients who develop H1N1 influenza and are nonresponsive to oral or inhaled antiviral therapies.12

Rosuvastatin (Crestor) has been approved by the FDA for treating heterozygous familial cholesterolemia in children ages 10-17.13

Telmisartan 80-mg tablets (Micardis) have been approved by the FDA for risk reduction of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years and older who are at high risk for major cardiovascular events, or who are not able to take angiotensin-converting enzyme inhibitors.14

Telmisartan/amlodipine tablets (Twynsta) have been approved by the FDA as a new combination for treating hypertension, either alone or in combination with other antihypertensive agents. This combination is not indicated for cardiovascular risk reduction. The tablets are available in the following strengths of telmisartan/amlodipine, respectively: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg.

Tranexamic acid (Lysteda) has been approved by the FDA for the treatment of menorrhagia.15 This is the first nonhormonal, oral therapeutic agent approved to treat this condition.16

Pipeline

Indacaterol is being investigated as a once-daily bronchodilator for treating adults with chronic obstructive pulmonary disease (COPD).17 Novartis has received a complete response letter from the FDA requesting additional data on the dosing of the agent. The company is working with the FDA to resolve these issues.

Rituximab injection (Rituxan) is approved for treating moderate to severe rheumatoid arthritis after patients have been treated with methotrexate, as well as non-Hodgkin’s lymphoma.18 Genentech/Biogen is attempting to expand rituximab use to treat patients earlier in the course of their disease. The FDA recently rejected this application, citing the rare but serious safety risk of developing progressive multifocal leukoencephalopathy.

Safety Information

Use of omeprazole and clopidogrel combination therapy should be avoided, according to new data from the FDA.18 Current data suggest that clopidogrel’s antiplatelet effect may be hindered by 50% with concomitant omeprazole therapy. Omeprazole blocks the conversion of clopidogrel to its active, antiplatelet form, thus significantly decreasing its effectiveness. It is not known if other proton-pump inhibitors interfere with clopidogrel’s effectiveness. Other drugs that should not be used with clopidogrel include esomeprazole (Nexium), cimetidine (Tagamet and Tagamet HB), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Sarafem, and Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid). TH

Michele B. Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=077312&TABLE1=OB_Rx. Accessed Nov. 19, 2009.

Covidien gets approval of generic pain drug. Forbes.com Web site. Available at: http://www.forbes.com/feeds/ap/2009/10/30/business-health-care-us-covidien-actiq_7069457.html. Accessed Nov. 19, 2009.

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/default.cfm Accessed Nov. 19, 2009.

Riley K. FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm. Accessed Nov. 19, 2009.

Qutenza Approved for Post-Shingles Nerve Pain. U.S. News and World Report Web site. Available at: health.usnews.com/articles/health/healthday/2009/11/17/qutenza-approved-for-post-shingles-nerve-pain.html. Accessed Nov. 19, 2009.

Nuvo shares surge on FDA pain cream approval. Reuters Web site. Available at: www.reuters.com/article/email/idUSN0543459820091105. Accessed Nov. 19, 2009.

Pennsaid. Nuvo Web site. Available at: www.nuvoresearch.com/pipeline/pennsaid.asp. Accessed Nov. 19, 2009.

BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/169396.php. Accessed Nov. 19, 2009.

Burgess S. FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm Accessed Nov. 19, 2009.

Prevacid 24hr available over-the-counter. Monthly Prescribing Reference Web site. Available at: www.empr.com/prevacid-24hr-available-over-the-counter/article/157592/. Accessed Nov. 19, 2009.

FDA Approves New Salix Product Exclusively in Catalent’s Zydis Fast Dissolve Technology. Catalent Web site. Available at: www.catalent.com/about-us/news/45. Accessed Nov. 19, 2009.

Peramivir to be Used for Special Swine Flu Cases. Pharmaceutical-Technology.com Web site. Available at: www.pharmaceutical-technology.com/News/News68102.html. Accessed Nov. 19, 2009.

Dennis M. AstraZeneca’s Crestor approved in US for paediatric use; Vimovo filed in Europe. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=41E54BF434C54C8E903A9EB4EF0839AA&logRowId=332380. Accessed Nov. 19, 2009.

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure. Boehringer Ingelheim Web site. Available at: us.boehringer-ingelheim.com/newsroom/2009/files/micardis_twynsta_approve_10-19-09.pdf. Accessed Nov. 19, 2009.

Todoruk M. FDA approves Xanodyne’s Lysteda for menorrhaegia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8FCB424A8E7147A08CEC9BFCD8A450D2&logRowId=337054. Accessed Nov. 19, 2009.

Xanodyne announces FDA approval of Lysteda for treatment of women with heavy menstrual bleeding. Xanodyne Web site. Available at: www.xanodyne.com/newsroom_details.asp?NewsId=61. Accessed Nov. 19, 2009.

Todoruk M. FDA requests additional data for Novartis’ COPD drug indacaterol. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B426F5ED30AB43A89338DAD0124168A7&logRowId=332718. Accessed Nov. 19, 2009.

Genentech and Biogen Idec Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis. Genentech Web site. Available at: www.gene.com/gene/news/press-releases/display.do?method=detail&id=12407. Accessed Nov. 19, 2009.

Walsh S. FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC. FDA Web site. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm. Accessed Nov. 19, 2009.

Issue

The Hospitalist - 2010(02)

Publications

Topics

Read more about Market Watch

Sections

Author(s)

Author(s)

New Generics

Fentanyl citrate troche/lozenge (generic Actiq) transmucosal lollipop1,2

Perindopril erbumine (generic Aceon) tablets3

New Drugs, Indications, Label Changes, and Dosage Forms

Capsaicin 8% patch (Qutenza) has been approved by the U.S. Food and Drug Administration (FDA) as a prescription medication to treat pain associated with post-herpetic neuralgia.4 The patch is a higher concentration than over-the-counter (OTC) products. The most common side effects in clinical trials were pain, swelling, itching, redness, and bumps at the application site, as well as blood pressure increases.5 Patch placement requires the use of a topical anesthetic and additional pain relief (ice or opioid pain relievers). Therefore, patch placement must be performed by a healthcare professional. Once the patch is applied, the patient must be observed for at least an hour, as there could be a significant increase in blood pressure.

Diclofenac sodium topical (Pennsaid) has been approved by the FDA as a topical treatment to manage knee osteoarthritis.6 The transdermal carrier dimethylsulfoxide (DMSO) is utilized to deliver active diclofenac sodium through the skin to the pain site.7

Exenatide injection (Byetta) has been approved by the FDA as monotherapy for treating patients with Type 2 diabetes mellitus, along with diet and exercise.8

Human papilloma virus (HPV) vaccine (Gardasil) has been approved by the FDA for preventing condyloma acuminata due to HPV types 6 and 11 in males ages 9 to 26.9 The makers hope that this vaccine will decrease the need to treat genital warts. Clinical studies showed that in males not infected with HPV at the beginning of the study, the vaccine was close to 90% effective in preventing genital warts caused by infection of HPV types 6 and 11. The manufacturer plans to obtain additional safety and effectiveness information in this patient population.

Lansoprazole 24HR (Prevacid OTC) 15-mg delayed-release capsules are available for treating frequent heartburn.10 The capsules will be available by prescription in both the 15-mg and 30-mg dosage strengths.

Metoclopramide HCl orally disintegrating tablet (Metozolv ODT) has been approved by the FDA for treating both acute and recurrent diabetic gastroparesis and for the short-term management (four to 12 weeks) of adults with documented symptomatic gastroesophageal reflux disease who do not respond to conventional therapy.11

Peramivir intravenous will be made available by the Centers for Disease Control (CDC) as an emergency treatment for children and adult patients who develop H1N1 influenza and are nonresponsive to oral or inhaled antiviral therapies.12

Rosuvastatin (Crestor) has been approved by the FDA for treating heterozygous familial cholesterolemia in children ages 10-17.13

Telmisartan 80-mg tablets (Micardis) have been approved by the FDA for risk reduction of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years and older who are at high risk for major cardiovascular events, or who are not able to take angiotensin-converting enzyme inhibitors.14

Telmisartan/amlodipine tablets (Twynsta) have been approved by the FDA as a new combination for treating hypertension, either alone or in combination with other antihypertensive agents. This combination is not indicated for cardiovascular risk reduction. The tablets are available in the following strengths of telmisartan/amlodipine, respectively: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg.

Tranexamic acid (Lysteda) has been approved by the FDA for the treatment of menorrhagia.15 This is the first nonhormonal, oral therapeutic agent approved to treat this condition.16

Pipeline

Indacaterol is being investigated as a once-daily bronchodilator for treating adults with chronic obstructive pulmonary disease (COPD).17 Novartis has received a complete response letter from the FDA requesting additional data on the dosing of the agent. The company is working with the FDA to resolve these issues.

Rituximab injection (Rituxan) is approved for treating moderate to severe rheumatoid arthritis after patients have been treated with methotrexate, as well as non-Hodgkin’s lymphoma.18 Genentech/Biogen is attempting to expand rituximab use to treat patients earlier in the course of their disease. The FDA recently rejected this application, citing the rare but serious safety risk of developing progressive multifocal leukoencephalopathy.

Safety Information

Michele B. Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=077312&TABLE1=OB_Rx. Accessed Nov. 19, 2009.

Covidien gets approval of generic pain drug. Forbes.com Web site. Available at: http://www.forbes.com/feeds/ap/2009/10/30/business-health-care-us-covidien-actiq_7069457.html. Accessed Nov. 19, 2009.

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/default.cfm Accessed Nov. 19, 2009.

Riley K. FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm. Accessed Nov. 19, 2009.

Qutenza Approved for Post-Shingles Nerve Pain. U.S. News and World Report Web site. Available at: health.usnews.com/articles/health/healthday/2009/11/17/qutenza-approved-for-post-shingles-nerve-pain.html. Accessed Nov. 19, 2009.

Nuvo shares surge on FDA pain cream approval. Reuters Web site. Available at: www.reuters.com/article/email/idUSN0543459820091105. Accessed Nov. 19, 2009.

Pennsaid. Nuvo Web site. Available at: www.nuvoresearch.com/pipeline/pennsaid.asp. Accessed Nov. 19, 2009.

BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/169396.php. Accessed Nov. 19, 2009.

Burgess S. FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm Accessed Nov. 19, 2009.

Prevacid 24hr available over-the-counter. Monthly Prescribing Reference Web site. Available at: www.empr.com/prevacid-24hr-available-over-the-counter/article/157592/. Accessed Nov. 19, 2009.

FDA Approves New Salix Product Exclusively in Catalent’s Zydis Fast Dissolve Technology. Catalent Web site. Available at: www.catalent.com/about-us/news/45. Accessed Nov. 19, 2009.

Peramivir to be Used for Special Swine Flu Cases. Pharmaceutical-Technology.com Web site. Available at: www.pharmaceutical-technology.com/News/News68102.html. Accessed Nov. 19, 2009.

Dennis M. AstraZeneca’s Crestor approved in US for paediatric use; Vimovo filed in Europe. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=41E54BF434C54C8E903A9EB4EF0839AA&logRowId=332380. Accessed Nov. 19, 2009.

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure. Boehringer Ingelheim Web site. Available at: us.boehringer-ingelheim.com/newsroom/2009/files/micardis_twynsta_approve_10-19-09.pdf. Accessed Nov. 19, 2009.

Todoruk M. FDA approves Xanodyne’s Lysteda for menorrhaegia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8FCB424A8E7147A08CEC9BFCD8A450D2&logRowId=337054. Accessed Nov. 19, 2009.

Xanodyne announces FDA approval of Lysteda for treatment of women with heavy menstrual bleeding. Xanodyne Web site. Available at: www.xanodyne.com/newsroom_details.asp?NewsId=61. Accessed Nov. 19, 2009.

Todoruk M. FDA requests additional data for Novartis’ COPD drug indacaterol. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B426F5ED30AB43A89338DAD0124168A7&logRowId=332718. Accessed Nov. 19, 2009.

Genentech and Biogen Idec Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis. Genentech Web site. Available at: www.gene.com/gene/news/press-releases/display.do?method=detail&id=12407. Accessed Nov. 19, 2009.

Walsh S. FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC. FDA Web site. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm. Accessed Nov. 19, 2009.

New Generics

Fentanyl citrate troche/lozenge (generic Actiq) transmucosal lollipop1,2

Perindopril erbumine (generic Aceon) tablets3

New Drugs, Indications, Label Changes, and Dosage Forms

Capsaicin 8% patch (Qutenza) has been approved by the U.S. Food and Drug Administration (FDA) as a prescription medication to treat pain associated with post-herpetic neuralgia.4 The patch is a higher concentration than over-the-counter (OTC) products. The most common side effects in clinical trials were pain, swelling, itching, redness, and bumps at the application site, as well as blood pressure increases.5 Patch placement requires the use of a topical anesthetic and additional pain relief (ice or opioid pain relievers). Therefore, patch placement must be performed by a healthcare professional. Once the patch is applied, the patient must be observed for at least an hour, as there could be a significant increase in blood pressure.

Diclofenac sodium topical (Pennsaid) has been approved by the FDA as a topical treatment to manage knee osteoarthritis.6 The transdermal carrier dimethylsulfoxide (DMSO) is utilized to deliver active diclofenac sodium through the skin to the pain site.7

Exenatide injection (Byetta) has been approved by the FDA as monotherapy for treating patients with Type 2 diabetes mellitus, along with diet and exercise.8

Human papilloma virus (HPV) vaccine (Gardasil) has been approved by the FDA for preventing condyloma acuminata due to HPV types 6 and 11 in males ages 9 to 26.9 The makers hope that this vaccine will decrease the need to treat genital warts. Clinical studies showed that in males not infected with HPV at the beginning of the study, the vaccine was close to 90% effective in preventing genital warts caused by infection of HPV types 6 and 11. The manufacturer plans to obtain additional safety and effectiveness information in this patient population.

Lansoprazole 24HR (Prevacid OTC) 15-mg delayed-release capsules are available for treating frequent heartburn.10 The capsules will be available by prescription in both the 15-mg and 30-mg dosage strengths.

Metoclopramide HCl orally disintegrating tablet (Metozolv ODT) has been approved by the FDA for treating both acute and recurrent diabetic gastroparesis and for the short-term management (four to 12 weeks) of adults with documented symptomatic gastroesophageal reflux disease who do not respond to conventional therapy.11

Peramivir intravenous will be made available by the Centers for Disease Control (CDC) as an emergency treatment for children and adult patients who develop H1N1 influenza and are nonresponsive to oral or inhaled antiviral therapies.12

Rosuvastatin (Crestor) has been approved by the FDA for treating heterozygous familial cholesterolemia in children ages 10-17.13

Telmisartan 80-mg tablets (Micardis) have been approved by the FDA for risk reduction of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years and older who are at high risk for major cardiovascular events, or who are not able to take angiotensin-converting enzyme inhibitors.14

Telmisartan/amlodipine tablets (Twynsta) have been approved by the FDA as a new combination for treating hypertension, either alone or in combination with other antihypertensive agents. This combination is not indicated for cardiovascular risk reduction. The tablets are available in the following strengths of telmisartan/amlodipine, respectively: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg.

Tranexamic acid (Lysteda) has been approved by the FDA for the treatment of menorrhagia.15 This is the first nonhormonal, oral therapeutic agent approved to treat this condition.16

Pipeline

Indacaterol is being investigated as a once-daily bronchodilator for treating adults with chronic obstructive pulmonary disease (COPD).17 Novartis has received a complete response letter from the FDA requesting additional data on the dosing of the agent. The company is working with the FDA to resolve these issues.

Rituximab injection (Rituxan) is approved for treating moderate to severe rheumatoid arthritis after patients have been treated with methotrexate, as well as non-Hodgkin’s lymphoma.18 Genentech/Biogen is attempting to expand rituximab use to treat patients earlier in the course of their disease. The FDA recently rejected this application, citing the rare but serious safety risk of developing progressive multifocal leukoencephalopathy.

Safety Information

Michele B. Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=077312&TABLE1=OB_Rx. Accessed Nov. 19, 2009.

Covidien gets approval of generic pain drug. Forbes.com Web site. Available at: http://www.forbes.com/feeds/ap/2009/10/30/business-health-care-us-covidien-actiq_7069457.html. Accessed Nov. 19, 2009.

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/default.cfm Accessed Nov. 19, 2009.

Riley K. FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm. Accessed Nov. 19, 2009.

Qutenza Approved for Post-Shingles Nerve Pain. U.S. News and World Report Web site. Available at: health.usnews.com/articles/health/healthday/2009/11/17/qutenza-approved-for-post-shingles-nerve-pain.html. Accessed Nov. 19, 2009.

Nuvo shares surge on FDA pain cream approval. Reuters Web site. Available at: www.reuters.com/article/email/idUSN0543459820091105. Accessed Nov. 19, 2009.

Pennsaid. Nuvo Web site. Available at: www.nuvoresearch.com/pipeline/pennsaid.asp. Accessed Nov. 19, 2009.

BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/169396.php. Accessed Nov. 19, 2009.

Burgess S. FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm Accessed Nov. 19, 2009.

Prevacid 24hr available over-the-counter. Monthly Prescribing Reference Web site. Available at: www.empr.com/prevacid-24hr-available-over-the-counter/article/157592/. Accessed Nov. 19, 2009.

FDA Approves New Salix Product Exclusively in Catalent’s Zydis Fast Dissolve Technology. Catalent Web site. Available at: www.catalent.com/about-us/news/45. Accessed Nov. 19, 2009.

Peramivir to be Used for Special Swine Flu Cases. Pharmaceutical-Technology.com Web site. Available at: www.pharmaceutical-technology.com/News/News68102.html. Accessed Nov. 19, 2009.

Dennis M. AstraZeneca’s Crestor approved in US for paediatric use; Vimovo filed in Europe. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=41E54BF434C54C8E903A9EB4EF0839AA&logRowId=332380. Accessed Nov. 19, 2009.

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure. Boehringer Ingelheim Web site. Available at: us.boehringer-ingelheim.com/newsroom/2009/files/micardis_twynsta_approve_10-19-09.pdf. Accessed Nov. 19, 2009.

Todoruk M. FDA approves Xanodyne’s Lysteda for menorrhaegia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8FCB424A8E7147A08CEC9BFCD8A450D2&logRowId=337054. Accessed Nov. 19, 2009.

Xanodyne announces FDA approval of Lysteda for treatment of women with heavy menstrual bleeding. Xanodyne Web site. Available at: www.xanodyne.com/newsroom_details.asp?NewsId=61. Accessed Nov. 19, 2009.

Todoruk M. FDA requests additional data for Novartis’ COPD drug indacaterol. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B426F5ED30AB43A89338DAD0124168A7&logRowId=332718. Accessed Nov. 19, 2009.

Genentech and Biogen Idec Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis. Genentech Web site. Available at: www.gene.com/gene/news/press-releases/display.do?method=detail&id=12407. Accessed Nov. 19, 2009.

Walsh S. FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC. FDA Web site. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm. Accessed Nov. 19, 2009.

Issue

The Hospitalist - 2010(02)

Issue

The Hospitalist - 2010(02)

Publications

Publications

Topics

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections

Disallow All Ads

Content Gating

No Gating (article Unlocked/Free)

Market Watch

Article Type

Changed

Fri, 09/14/2018 - 12:32

Display Headline

Market Watch

Author(s)

New Generics

Tamsulosin (generic Flomax) capsules should be available March 2, 20101

New Drugs, Indications, Dosage Forms, and Approvals

C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2

Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3

Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3

Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4

Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5

Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.

Pipeline

Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9

Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.

Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.

Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.

Safety Information

Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.

Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.

FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.

Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.

Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.

Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.

Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.

Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.

Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.

Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.

Dennis M. AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=3B158484CA7A47B99CEA373CB2ABFFA2&logRowId=330336. Accessed Oct. 13, 2009.

Gever J, Zaleznik DF, Caputo D. EASD: Phase III data look good for novel diabetes drug. Medpage Today Web site. Available at: http://www.medpagetoday.com/MeetingCoverage/EASD/16270. Accessed Oct. 11, 2009.

Dennis M. Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=EDBA0E3366E2477DB714674E9C19821D&logRowId=329838. Accessed Oct. 13, 2009.

Multiple sclerosis therapy FTY720 reduces relapses and disability progression. The Multiple Sclerosis Resource Centre Web site. Available at: http://www.msrc.co.uk/printable.cfm?pageid=1309. Accessed Oct. 13, 2009.

NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA. NicOx Web site. Available at: http://www.nicox.com/upload/PR_NDA_submission-250909__EN.pdf. Accessed Oct. 13, 2009.

Riley K. FDA requires boxed warning for promethazine hydrochloride injection. FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm. Accessed Oct. 13, 2009.

Januvia package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf. Accessed Oct. 13, 2009.

Information for healthcare professionals—acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm. Accessed Sept. 26, 2009.

Issue

The Hospitalist - 2010(01)

Publications

Read more about Market Watch

Sections

Government and Regulations

Author(s)

Author(s)

New Generics

Tamsulosin (generic Flomax) capsules should be available March 2, 20101

New Drugs, Indications, Dosage Forms, and Approvals

C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2

Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3

Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3

Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4

Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5

Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.

Pipeline

Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9

Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.

Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.

Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.

Safety Information

Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.

Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.

FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.

Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.

Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.

Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.

Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.

Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.

Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.

Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.

Dennis M. AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=3B158484CA7A47B99CEA373CB2ABFFA2&logRowId=330336. Accessed Oct. 13, 2009.

Gever J, Zaleznik DF, Caputo D. EASD: Phase III data look good for novel diabetes drug. Medpage Today Web site. Available at: http://www.medpagetoday.com/MeetingCoverage/EASD/16270. Accessed Oct. 11, 2009.

Dennis M. Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=EDBA0E3366E2477DB714674E9C19821D&logRowId=329838. Accessed Oct. 13, 2009.

Multiple sclerosis therapy FTY720 reduces relapses and disability progression. The Multiple Sclerosis Resource Centre Web site. Available at: http://www.msrc.co.uk/printable.cfm?pageid=1309. Accessed Oct. 13, 2009.

NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA. NicOx Web site. Available at: http://www.nicox.com/upload/PR_NDA_submission-250909__EN.pdf. Accessed Oct. 13, 2009.

Riley K. FDA requires boxed warning for promethazine hydrochloride injection. FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm. Accessed Oct. 13, 2009.

Januvia package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf. Accessed Oct. 13, 2009.

Information for healthcare professionals—acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm. Accessed Sept. 26, 2009.

New Generics

Tamsulosin (generic Flomax) capsules should be available March 2, 20101

New Drugs, Indications, Dosage Forms, and Approvals

C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2

Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3

Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3

Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4

Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5

Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.

Pipeline

Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9

Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.

Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.

Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.

Safety Information

Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.

Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.

FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.

Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.

Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.

Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.

Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.

Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.

Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.

Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.

Dennis M. AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=3B158484CA7A47B99CEA373CB2ABFFA2&logRowId=330336. Accessed Oct. 13, 2009.

Gever J, Zaleznik DF, Caputo D. EASD: Phase III data look good for novel diabetes drug. Medpage Today Web site. Available at: http://www.medpagetoday.com/MeetingCoverage/EASD/16270. Accessed Oct. 11, 2009.

Dennis M. Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=EDBA0E3366E2477DB714674E9C19821D&logRowId=329838. Accessed Oct. 13, 2009.

Multiple sclerosis therapy FTY720 reduces relapses and disability progression. The Multiple Sclerosis Resource Centre Web site. Available at: http://www.msrc.co.uk/printable.cfm?pageid=1309. Accessed Oct. 13, 2009.

NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA. NicOx Web site. Available at: http://www.nicox.com/upload/PR_NDA_submission-250909__EN.pdf. Accessed Oct. 13, 2009.

Riley K. FDA requires boxed warning for promethazine hydrochloride injection. FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm. Accessed Oct. 13, 2009.

Januvia package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf. Accessed Oct. 13, 2009.

Information for healthcare professionals—acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm. Accessed Sept. 26, 2009.

Issue

The Hospitalist - 2010(01)

Issue

The Hospitalist - 2010(01)

Publications

Publications

Article Type

Display Headline

Market Watch

Display Headline

Market Watch

Sections