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.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1821.85 |
Dr. Reddys Lab | 1351.50 |
Cipla | 1486.40 |
Lupin | 2182.40 |
Zydus Lifesciences | 980.30 |
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