Zydus Lifesciences gets U.S. FDA tentative nod for diabetes drug

Zydus Lifesciences has received tentative support from the U.S. Food and Drug Administration (U.S. FDA) for diabetes cause Dapagliflozin Tablets, 5 mg and 10 mg, a generic of AstraZeneca Pharmaceuticals Farxiga Tablets, 5 mg and 10 mg.

The merchandise volition beryllium manufactured astatine the group’s formulation manufacturing installation astatine SEZ, Ahmedabad. Dapagliflozin tablets had yearly income of $10,486.9 cardinal successful the U.S., Zydus said, citing IQVIA MAT December 2025 numbers.

Dapagliflozin is simply a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated arsenic an adjunct to fare and workout to amended glycaemic power successful adults with benignant 2 diabetes mellitus, it said successful a release.

EOM