Zydus Lifesciences gets USFDA final approval to market diabetes drug

New Delhi : Zydus Lifesciences Ltd on Monday said it has received final approval from the US health regulator to market its generic version of Empagliflozin and Metformin Hydrochloride tablets used for controlling high blood sugar in adults with type 2 diabetes mellitus.

The approval by the US Food and Drug Administration (USFDA) is for Empagliflozin and Metformin Hydrochloride tablets in strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, the company said in a regulatory filing.

These are the generic equivalent of the patented product Synjardy.

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

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. These are also used to lower the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease, the company said.

Citing IQVIA May 2022 data, the company said Synjardy (Empagliflozin and Metformin Hydrochloride) tablets had annual sales of USD 281 million in the US.

The group now has 316 approvals and has so far filed over 420 abbreviated new drug applications since the commencement of the filing process in FY2003-04, the filing said.