USFDA denies Sun Pharma Advanced Research Company Ltd's appeal of NDA for Taclantis™

The Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has denied Sun Pharma Advanced Research Company Ltd's appeal of the Complete Response Letter in relation to the New Drug Application (NDA) for Taclantis™.

In its Appeal Denied letter, the OND requested the conduct of a new Phase 3 study in metastatic breast cancer patients to support any potential resubmission of the Taclantis™ NDA. The Company will review FDA's response and decide on appropriate next steps soon.

Shares of SUN PHARMA ADVANCED RESEARCH COMPANY LTD. was last trading in BSE at Rs.173.65 as compared to the previous close of Rs. 172.65. The total number of shares traded during the day was 27955 in over 375 trades.

The stock hit an intraday high of Rs. 175.6 and intraday low of 172. The net turnover during the day was Rs. 4866311.

Source : Equity Bulls

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