USFDA nod to Zydus Lifesciences diabetes drug
Ahmedabad: Zydus Lifesciences Limited 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, Zydus 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.
Type 2 diabetes mellitus is a chronic metabolic disorder characterized by high blood sugar levels due to insulin resistance and relative insulin deficiency.
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 US$ 9.5 bn.
Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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