Unichem Labs gets tentative US FDA approval for Sitagliptin Tablets USP

Approved

Unichem Laboratories has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (USFDA) for a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp (Merck).

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product will be commercialised from Unichem’s Goa Plant on receipt of full approval.

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