Zydus receives USFDA tentative approval for dapagliflozin tablets

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration for Dapagliflozin Tablets in 5 mg and 10 mg strengths. The reference listed drug for the approval is Farxiga Tablets, 5 mg and 10 mg.

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

The company stated that Dapagliflozin tablets will be manufactured at the group’s formulation manufacturing facility located at the SEZ in Ahmedabad.

According to IQVIA MAT December 2025 data, Dapagliflozin tablets recorded annual sales of USD 10,486.9 million in the United States.

With this approval, the group now has 430 approvals. Zydus Lifesciences has filed a total of 505 abbreviated new drug applications since the commencement of the filing process in the financial year 2003–04, as of 31 December 2025.

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