FDA Approves Zituvimet XR
FDA Approves Zituvimet XR (sitagliptin and metformin hydrochloride) Extended-Release Tablets for Adults with Type 2 Diabetes
Ahmedabad, India, 19 July 2024 Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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. 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. *
Source: Zydus Lifesciences Limited
Posted: July 2024
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- FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellitus - November 6, 2023
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