Zydus Cadila’s Sitagliptin base tablets receive tentative approval from FDA

Zydus Cadila today announced that its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets. Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (sitagliptin phosphate), the company said in a statement.

It also said that on 31st 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 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 2nd September, 2021.