Zydus receives final approval from US FDA for Empagliflozin and Metformin Hydrochloride Tablets

Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market Empagliflozin and Metformin Hydrochloride Tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg (US RLD: Synjardy), a company statement notified.

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type-II diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type-II diabetes mellitus and established cardiovascular disease. The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India, the statement added.