USFDA27 Nov 2025, 04:41 pm
Zydus Lifesciences Receives Tentative Approval from USFDA for Empagliflozin and Linagliptin Tablets
AI Summary
Zydus Lifesciences Ltd. has received tentative approval from the USFDA for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg. These tablets 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. The tablets will be produced at Zydus' formulation manufacturing facility at SEZ, Ahmedabad. The annual sales of the USRLD (Glyxambi® Tablets, 10 mg/5 mg and 25 mg/5 mg) in the United States was USD 215.8 mn (IQVIA MAT Sept-2025). Zydus now has 428 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus receives tentative approval from USFDA for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg
- The tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus
- The tablets will be produced at Zydus' formulation manufacturing facility at SEZ, Ahmedabad
- The annual sales of the USRLD (Glyxambi® Tablets, 10 mg/5 mg and 25 mg/5 mg) in the United States was USD 215.8 mn (IQVIA MAT Sept-2025)
- Zydus now has 428 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003-04