Zydus Cadila arm gets USFDA nod for Sitagliptin base tablets
Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company's subsidiary has received tentative approval from the United States Food and Drug Administration (USFDA) 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,...
Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company's subsidiary has received tentative approval from the United States Food and Drug Administration (USFDA) 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). 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 (USFDA) 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.
Read also: Zydus needle-free COVID vaccine ZyCoV-D expected to be available from October
Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd