Zydus Lifesciences has received approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for ZITUVIO (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. ZITUVIO contains active ingredient Sitagliptin, 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 USFDA standards. ZITUVIO is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products. According to IQVIA (MAT August 2023), U.S. market for DPP-IV inhibitors and its combinations is $10 billion.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
