Zydus gets FDA approval for type 2 diabetes drug

India Pharma Outlook Team | Monday, 11 July 2022

 India Pharma Outlook Team

The US health authorities gave final approval to Zydus Lifesciences, Ahmedabad-based pharmaceutical company to market its generic version of Empagliflozin and Metformin Hydrochloride tablets, which are intended to lower blood sugar levels in persons with type 2 diabetes. The approval by the U.S. Food and Drug Administration 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. It also stated that the medication would be produced at the group's formulation facility in Ahmedabad's SEZ.

To enhance glycemic control in individuals with type 2 diabetes mellitus, empagliflozin and metformin hydrochloride tablets are taken in conjunction with a healthy diet and exercise. According to the manufacturer, they are also used to reduce the risk of cardiovascular death in people with type 2 diabetes mellitus and advanced cardiovascular disease.

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