USFDA gives final nod for Type 2 Diabetes drug

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

AhmedabadZydus Lifesciences Ltd has received final USFDA approval to market Empagliflozin and Metformin Hydrochloride Tablets in 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg strengths (US RLD: Synjardy).

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic 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.

The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India, the company said in a statement.

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