Zydus gets USFDA nod for Empagliflozin, Metformin tablets

AHMEDABAD: Ahmedabad-headquartered pharma giant, Zydus Lifesciences Limited on Monday announced in its regulatory filing that it has received final approval from the US Food and Drug Administration (USFDA) to market Empagliflozin and Metformin Hydrochloride tablets.

The company can market the two drugs in the strengths of 5mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg.

The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India.

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type-2 diabetes mellitus and established cardiovascular disease.