Zydus gains US FDA approval for diabetes drug Zituvio

Indian generics major Zydus Lifesciences (NYSE: ZYDUSLIFE) has announced the US Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zituvio (sitagliptin) tablets, 25mg, 50mg, and 100mg.

Sitagliptin, the active ingredient in Merck & Co’s Januvia, Janumet and Janumet XR brands, is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The approval of Zituvio is based on research, development, regulatory and manufacturing work performed by Zydus teams. Zituvio has undergone quality testing for nitrosamines and potential genotoxic impurities as per current US FDA standards. Zituvio is compliant with current US FDA standards of nitrosamines in sitagliptin containing products.