Zydus receives final approval from the USFDA for its NDA Zituvimet TM XR extended release tablets

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).

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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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