Biocon Pharma Receives Tentative Approval from US FDA for Sitagliptin Tablets

Biocon Pharma Limited, a wholly-owned subsidiary of Biocon Ltd, has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its ANDA for Sitagliptin Tablets USP, in 25 mg, 50 mg and 100 mg strengths. This approval is for Sitagliptin tablets which are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This approval will further strengthen Biocon’s portfolio of vertically integrated drug products.