Zydus Lifesciences Limited, a prominent global healthcare provider, has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Zituvimetᵀᴹ XR (sitagliptin and metformin hydrochloride) extended-release tablets. This approval enables Zydus to market the medication in the U.S.
Zituvimetᵀᴹ XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This approval is significant as Zydus now has all three NDAs of its Sitagliptin (base) and combination franchise approved through the 505(b)(2) route. Impressively, each of these NDAs achieved First-Cycle Approval (FCA), underscoring Zydus’s commitment to meeting rigorous regulatory standards efficiently. choline glycerophosphate gpc 28319 77 9
Prescribing Zituvimetᵀᴹ XR (sitagliptin and metformin hydrochloride) extended-release tablets offer several potential benefits over other available drugs for managing type 2 diabetes mellitus:
The product will be manufactured at Zydus’s state-of-the-art formulation manufacturing facility located in Ahmedabad SEZ, India, ensuring high-quality production standards.
According to IQVIA (MAT May 2024), the U.S. market for DPP-IV inhibitors and their combinations is valued at $9.5 billion, reflecting a substantial market opportunity for Zituvimetᵀᴹ XR.
By offering a combination of sitagliptin and metformin in an extended-release formulation, Zituvimetᵀᴹ XR provides a comprehensive approach to managing type 2 diabetes, addressing multiple pathophysiological defects with the convenience of once-daily dosing, potentially improving patient outcomes and adherence.
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