Lupin receives US FDA’s tentative approval for Empagliflozin and Linagliptin Tablets

Pharma major Lupin announced that it has received tentative approval for its Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg, from the United States Food and Drug Administration (US FDA) to market a generic version of Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

Empagliflozin and Linagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg (RLD: Glyxambi®) had an annual sales of approximately USD 242 million in the U.S. (IQVIA MAT Mar 2020).