Zydus Gets USFDA Nod for Dapagliflozin Generic

New Delhi, Apr 8 (PTI) Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets indicated to control blood sugar in adults with type 2 diabetes mellitus.

The approval by the US Food and Drug Administration (USFDA) is for dapagliflozin tablets of strengths 5 mg and 10 mg, Zydus Lifesciences said in a regulatory filing.

Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, the company said.


Zydus said it is eligible for 180 days of shared generic drug marketing exclusivity for dapagliflozin tablets, 5 mg and 10 mg.

The tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad, it added.

Dapagliflozin tablets had annual sales of USD 10.2 billion in the US, the company said citing IQVIA MAT February 2026 data.