Zydus Lifesciences 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 glycemic control in adults with type 2 diabetes mellitus. The annual sales for Empagliflozin and Linagliptin Tablets were USD 215.8 million in the United States as of September 2025.
USFDA Approval Received
Zydus Lifesciences Limited has secured 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. The announcement was made on November 27, 2025.
Therapeutic Use
The approved tablets, a combination of empagliflozin and linagliptin, are prescribed as an addition to diet and exercise. This treatment aims to improve blood sugar control in adults diagnosed with type 2 diabetes, particularly when treatment with both empagliflozin and linagliptin is deemed appropriate.
Manufacturing and Market Data
The production of Empagliflozin and Linagliptin Tablets will occur at Zydus’s formulation manufacturing facility located at SEZ, Ahmedabad. As of September 2025, the annual sales for these tablets reached USD 215.8 million in the United States, according to IQVIA MAT data.
ANDA Filings
As of the announcement date, the group holds 428 approvals and has submitted 487 ANDAs since the initiation of the filing process in fiscal year 2003-04.
Source: BSE
