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FDA Approves Steglatro for Adults with T2D

Pfizer news release; 2017 Dec 22

Publish date:: January 2, 2018

FDA has approved Steglatro (ertugliflozin) oral tablets for the treatment of adults with type 2 diabetes. The approval was granted to Merck and Pfizer Inc.

Indications: Steglatro is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage and administration: Recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase dose to 15 mg once daily in those tolerating Steglatro and needing additional glycemic control. Assess renal function before initiating Steglatro and periodically thereafter.

Adverse reactions: The most common adverse reactions associated with Steglatro (incidence ≤5%) were female genital mycotic infections.

Citation:

FDA approves SGLT2 inhibitor Steglatro (ertugliflozin) for adults with type 2 diabetes. [news release]. Merck, Pfizer: December 22, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf. Accessed December 24, 2017.

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