
The United States Food and Drug Administration (USFDA) has granted Zydus Lifesciences Limited final approval for its New Drug Application (NDA) to market ZituvimetTM XR (sitagliptin and metformin hydrochloride) extended-release tablets.
With this, Zydus has obtained approval for all three of the NDAs for Sitagliptin (base) and combination franchise through the 505(b)(2) route. Notably, all three NDAs received first-cycle approval (FCA).
As per the company, “ZituvimetTM 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), the US market for DPP-IV inhibitors and its combinations is US$ 9.5 bn.
Zydus Lifesciences shares were down 2.16% at ₹1159.55 on the NSE as of 11:27 AM.
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