Zydus receives USFDA tentative approval for Dapagliflozin Tablets

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga Tablets, 5 mg and 10 mg).

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

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

Dapagliflozin tablets had annual sales of USD 10,486.9 mn in the United States (IQVIA MAT December 2025).

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