Zydus Cadila's Sitagliptin base tablets receives 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).

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.

Shares of Cadila Healthcare Ltd. was last trading in BSE at Rs. 554.3 as compared to the previous close of Rs. 556.1. The total number of shares traded during the day was 79170 in over 2109 trades.

The stock hit an intraday high of Rs. 560 and intraday low of 553. The net turnover during the day was Rs. 44003557.

Source : Equity Bulls

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