USFDA nod to Zydus Lifesciences diabetes drug
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-07-19 09:47 GMT | Update On 2024-07-19 09:47 GMT
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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).
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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