Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus
AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.
- 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.
- "The ZITUVIO™ approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.
- "We are pleased to be able to receive such a milestone approval for Zydus.