Zydus Cadila receives USFDA tentative approval for Sitagliptin base tablets

On 31 October 2020, Zydus filed a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FD&C Act) with the United States Food and Drug Administration (FDA) seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets. Zydus'

NDA received tentative approval upon completion of the first review cycle on 02 September 2021.