Empagliflozin is a medication used for treatment of type-2 diabetes together with diet and exercise. This medicine is also used to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and established cardiovascular disease.

On 10-Apr-2020, Zydus cedilla announced that it has received temporary approval from the USFDA for marketing Empagliflozin Tablets, in the strengths of 10 mg and 25 mg (US RLD: Jardiance® Tablets) in United States.

The medicine would be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. The group now has 286 approvals and has so far filed over 386 ANDAs since the commencement of the filing process in FY 2003-04.

Reference:

https://www.zyduscadila.com/public/pdf/pressrelease/Zydus-receives-tentative-approval-from-the-USFDA-for-Empagliflozin-Tablets.pdf

error: Content is protected !!