FDA gives Zydus Cadila tentative OK for generic Farxiga

Zydus Cadila has received a tentative nod from the Food and Drug Administration for its dapagliflozin tablets, a generic of Farxiga. The drug has been tentatively approved in dosage strengths of 5 mg and 10 mg. 

Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors, Zydus Cadila said.

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