Brief: Sun Pharma Advanced Research gets complete response letter from FDA for Xelpros

Sun Pharma Advanced Research

22/12/2016 03:31

Dec 22 (Reuters) - Sun Pharma Advanced Research Company Ltd 
 SPRC.NS  
    * Update on Xelpros (latanoprost ophthalmic emulsion) NDA 
    * Says co got complete response letter from FDA for Xelpros 
    * Says CRL references recent FDA inspection at Sun Pharma 
Industries' halol unit 
    *  No requirement of additional data from the USFDA on CRL 
    * Says CRL indicates satisfactory resolutions of 
deficiencies identified during inspection is needed for approval 
of Xelpros 
 
Source text: http://bit.ly/2i2Yr2x 
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