Zydus Lifesciences Gains USFDA Approval for Dapagliflozin Tablets
Filing Summary
Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin Tablets, available in 5 mg and 10 mg dosages. This approval grants Zydus 180 days of shared generic drug exclusivity. The tablets will be produced at Zydus’s manufacturing facility in Ahmedabad. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, is used to improve glycaemic control in adults with type 2 diabetes mellitus. The company has secured 436 approvals and filed 505 ANDAs since FY 2003-04.
Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin Tablets, in 5 mg and 10 mg dosages. This approval allows Zydus 180 days of shared generic drug exclusivity for these tablets.
The Dapagliflozin Tablets are a sodium-glucose cotransporter 2 (SGLT2) inhibitor. They are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The tablets will be manufactured at the company’s formulation manufacturing facility located at SEZ, Ahmedabad.
According to IQVIA MAT February 2026 data, Dapagliflozin tablets had annual sales of USD 10.2 billion in the United States. This approval marks another milestone for Zydus, which now holds 436 approvals and has filed 505 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Ltd focuses on the development and manufacturing of a wide range of pharmaceutical products. The company prioritizes expanding its portfolio of generic drugs and enhancing its presence in international markets. Zydus continues to invest in research and development to support its strategic growth initiatives.