Zydus Lifesciences gets USFDA’s final approval for Zituvimet XR extended-release tablets

19 Jul 2024 Evaluate

Zydus Lifesciences has received final approval for its New Drug Application (NDA) from the United States Food and Drug Administration (USFDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets. With this, the company has all three NDAs of Sitagliptin (base) and combination franchise approved through the 505(b) (2) route. Notably, all the three NDAs achieved First-Cycle Approval (FCA). 

Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India. According to IQVIA (MAT May 2024), U.S. market for DPP-IV inhibitors and its combinations is $9.5 billion.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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