Unichem Labs diabetes drug Sitagliptin gets USFDA approval
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Mumbai: Unichem Laboratories Limited has recently announced that the company has received tentative approval for Abbreviated New Drug Application (ANDA) of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (USFDA).
The product is a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp (Merck).
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Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Product will be commercialized from Unichem's Goa Plant on receipt of full approval.
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