Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (US FDA) for Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg (USRLD: Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg).
Empagliflozin and Linagliptin Tablets (10 mg/5 mg and 25 mg/5 mg) in a combination are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.
Empagliflozin and Linagliptin Tablets had annual sales of USD 215.8 mn in the United States (IQVIA MAT Sept-2025).
The group now has 428 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.