Zydus Lifesciences has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for diabetes drug Dapagliflozin Tablets, 5 mg and 10 mg, a generic of AstraZeneca Pharmaceuticals Farxiga Tablets, 5 mg and 10 mg.
The product will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad. Dapagliflozin tablets had annual sales of $10,486.9 million in the U.S., Zydus said, citing IQVIA MAT December 2025 numbers.
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, it said in a release.
EOM
Published – February 04, 2026 08:18 pm IST
