• Source : Press Release
  • Date : 2020-09-16
  • Event type : Tentative Approval
  • Companies : Zydus Cadila

Zydus Cadila Gets Tentative USFDA Nod for Empagliflozin and Linagliptin Tablets

Zydus Cadila has received tentative approval from the USFDA to market Empagliflozin and Linagliptin Tablets (US RLD: Glyxambi Tablets) in the strengths of 10 mg/5 mg and 25 mg/5 mg. This medication contains a combination of Empagliflozin and Linagliptin.

Empagliflozin and Linagliptin are oral diabetes medicines that help control blood sugar levels. The drug is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

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

The group now has 299 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.