Zydus gets tentative USFDA approval for diabetes combination tablets

Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for empagliflozin and linagliptin tablets in strengths of 10 mg/5 mg and 25 mg/5 mg. These tablets are indicated as an adjunct to diet and exercise for improving glycaemic control in adults with type 2 diabetes mellitus. The combination tablets will be manufactured at the group's formulation facility in SEZ, Ahmedabad.

The approved tablets correspond to the USRLD Glyxambi® Tablets, which recorded annual sales of $215.8 million in the United States, as per IQVIA MAT data for September 2025. This approval adds to Zydus’s growing portfolio, bringing their total number of approvals to 428.

Since the commencement of its filing process in FY 2003-04, Zydus has filed 487 Abbreviated New Drug Applications (ANDAs) as of September 30, 2025.