FDA tentatively approves Unichem’s generic Januvia
Unichem's generic Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
Unichem has obtained tentative approval from the Food and Drug Administration for sitagliptin tablets in dosage strengths of 25 mg, 50 mg, and 100 mg
The medication is a generic of Merck Sharpe and Dohme’s Januvia.
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.
The product will be commercialized from Unichem’s Goa plant on receipt of full approval.