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Zydus Cadila’s Sitagliptin base tablets receives Tentative Approval from FDA

 

 

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Zydus Cadila’s Sitagliptin base tablets receives Tentative Approval from FDA

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and  vaccines.  The  group  employs  23000  people  worldwide  and  is  dedicated  to  creating  healthier communities globally.

Zydus Cadila 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).

OnOctober  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

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