Lupin gets USFDA’s tentative nod for Empagliflozin, Linagliptin Tablets
24th Jul 2020

Lupin 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 (USFDA) 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 $242 million in the U.S. (IQVIA MAT Mar 2020).

Lupin is an innovation led transnational pharmaceutical company headquartered in Mumbai, India.