Zydus receives final approval from USFDA for Dapagliflozin Tablets, 5 mg and 10 mg
Ahmedabad: Zydus Lifesciences Limited (“Zydus”) has received final 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. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Dapagliflozin Tablets, 5 mg and 10 mg. Dapagliflozin tablets will be manufactured at the
