Zydus Lifesciences 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.
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