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Product News July 2019

AbbVie to Acquire Allergan

AbbVie Inc and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Furthermore, Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise, and international infrastructure. For more information, visit www.abbvie.com and www.allergan.com.

Avène Launches Mineral Sunscreen Fluids

Pierre Fabre Dermo-Cosmetique introduces Avène Mineral Sunscreen Fluids SPF 50+ in both tinted and nontinted varieties. With active ingredients titanium dioxide (11.4%) and zinc oxide (14.6%), both products provide broad-spectrum UVA and UVB protection and are free from octinoxate and oxybenzone (reef friendly). These lightweight lotions are ideal for use on the face; they absorb quickly and can be layered invisibly under makeup. Additionally, the tinted fluid offers protection against blue light. For more information, visit www.aveneusa.com.

CoolTone Device Clearance Expanded

Allergan announces US Food and Drug Administration clearance of the nonsurgical CoolTone device for the improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone also is indicated for the strengthening, toning, and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in a more defined and toned appearance. For more information, visit www.cooltonebycoolsculpting.com.

Duobrii Lotion for Plaque Psoriasis Now Available

Ortho Dermatologics announces the US launch of Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%. Duobrii was approved by the US Food and Drug Administration in April 2019 for the treatment of plaque psoriasis in adult patients, offering psoriasis patients a treatment with strong efficacy and an extended duration of use in a once-daily lotion that can be dosed to clearance. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited to 2 to 4 weeks, and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to 8 weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved. For more information, visit www.duobrii.com.

Zika Virus Diagnostic Test Receives Marketing Authorization

The US Food and Drug Administration authorizes marketing of the ZIKV Detect 2.0 IgM Capture ELISA (enzymelinked immunosorbent assay)(InBios International, Inc) for the qualitative detection of Zika virus IgM antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood; IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the Centers for Disease Control and Prevention’s Zika virus epidemiologic criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel. For more information, visit www.inbios.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@mdedge.com.

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AbbVie to Acquire Allergan

AbbVie Inc and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Furthermore, Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise, and international infrastructure. For more information, visit www.abbvie.com and www.allergan.com.

Avène Launches Mineral Sunscreen Fluids

Pierre Fabre Dermo-Cosmetique introduces Avène Mineral Sunscreen Fluids SPF 50+ in both tinted and nontinted varieties. With active ingredients titanium dioxide (11.4%) and zinc oxide (14.6%), both products provide broad-spectrum UVA and UVB protection and are free from octinoxate and oxybenzone (reef friendly). These lightweight lotions are ideal for use on the face; they absorb quickly and can be layered invisibly under makeup. Additionally, the tinted fluid offers protection against blue light. For more information, visit www.aveneusa.com.

CoolTone Device Clearance Expanded

Allergan announces US Food and Drug Administration clearance of the nonsurgical CoolTone device for the improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone also is indicated for the strengthening, toning, and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in a more defined and toned appearance. For more information, visit www.cooltonebycoolsculpting.com.

Duobrii Lotion for Plaque Psoriasis Now Available

Ortho Dermatologics announces the US launch of Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%. Duobrii was approved by the US Food and Drug Administration in April 2019 for the treatment of plaque psoriasis in adult patients, offering psoriasis patients a treatment with strong efficacy and an extended duration of use in a once-daily lotion that can be dosed to clearance. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited to 2 to 4 weeks, and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to 8 weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved. For more information, visit www.duobrii.com.

Zika Virus Diagnostic Test Receives Marketing Authorization

The US Food and Drug Administration authorizes marketing of the ZIKV Detect 2.0 IgM Capture ELISA (enzymelinked immunosorbent assay)(InBios International, Inc) for the qualitative detection of Zika virus IgM antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood; IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the Centers for Disease Control and Prevention’s Zika virus epidemiologic criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel. For more information, visit www.inbios.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@mdedge.com.

AbbVie to Acquire Allergan

AbbVie Inc and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care, and virology. Furthermore, Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise, and international infrastructure. For more information, visit www.abbvie.com and www.allergan.com.

Avène Launches Mineral Sunscreen Fluids

Pierre Fabre Dermo-Cosmetique introduces Avène Mineral Sunscreen Fluids SPF 50+ in both tinted and nontinted varieties. With active ingredients titanium dioxide (11.4%) and zinc oxide (14.6%), both products provide broad-spectrum UVA and UVB protection and are free from octinoxate and oxybenzone (reef friendly). These lightweight lotions are ideal for use on the face; they absorb quickly and can be layered invisibly under makeup. Additionally, the tinted fluid offers protection against blue light. For more information, visit www.aveneusa.com.

CoolTone Device Clearance Expanded

Allergan announces US Food and Drug Administration clearance of the nonsurgical CoolTone device for the improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone also is indicated for the strengthening, toning, and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in a more defined and toned appearance. For more information, visit www.cooltonebycoolsculpting.com.

Duobrii Lotion for Plaque Psoriasis Now Available

Ortho Dermatologics announces the US launch of Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%. Duobrii was approved by the US Food and Drug Administration in April 2019 for the treatment of plaque psoriasis in adult patients, offering psoriasis patients a treatment with strong efficacy and an extended duration of use in a once-daily lotion that can be dosed to clearance. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited to 2 to 4 weeks, and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to 8 weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved. For more information, visit www.duobrii.com.

Zika Virus Diagnostic Test Receives Marketing Authorization

The US Food and Drug Administration authorizes marketing of the ZIKV Detect 2.0 IgM Capture ELISA (enzymelinked immunosorbent assay)(InBios International, Inc) for the qualitative detection of Zika virus IgM antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood; IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection and/or those who meet the Centers for Disease Control and Prevention’s Zika virus epidemiologic criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel. For more information, visit www.inbios.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@mdedge.com.

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