U.S. FDA approval for sitagliptin base for Zydus Cadilla Arm

Zydus Cadila, one of the leading Indian pharmaceutical companies, announced its tentative approval for its new sitagliptin bases 25, 50 and 100 mg tablets from the United States Food & Drug Administration (FDA).

Zydus’ base contains the active moisture sitagliptine in a form different from the one used in Januvia, the branded reference product (sitagliptin phosphate).

On October 31, 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 September 2, 2021.ganizing activities like conferences, debates, poster-oral presentations, quiz contests, essay writing competitions etc. in the area of pharmacovigilance a