Zydus Cadila gets FDA tentative approval for Sitagliptin base tablets
Zydus Cadila said that its subsidiary has been granted tentative approval from the US Food and Drug Administration (FDA) for its new drug application (NDA) for Sitagliptin base 25, 50, and 100 mg tablets.
The Indian pharma company said that Sitagliptin base has the active moiety Sitagliptin in a different form than the one used in the branded reference product —Januvia (Sitagliptin Phosphate), owned by pharma giant Merck.
Januvia is an anti-diabetic medication used for the treatment of type 2 diabetes.
Zydus Cadila had filed an NDA in October 2020 under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FD&C Act) with the FDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets.
The NDA was given tentative approval after the completion of the first review cycle.