Zydus Lifesciences announced that the US Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIMET (Sitagliptin and Metformin hydrochloride) tablets, 50 mg/500 mg and 50 mg/1000 mg.
ZITUVIMET contains active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The approval of ZITUVIMET is based on research, development, regulatory, and manufacturing work performed by Zydus teams. ZITUVIMET has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIMET is compliant with current USFDA standards of nitrosamines in Sitagliptin containing products.
According to IQVIA (MAT Aug-2023), US market for DPP-IV inhibitors and their combinations is $ 10 billion.