SPARC receives Complete Response Letter from USFDA for ‘Xelpros’

22 Dec 2016 Evaluate

Sun Pharma Advanced Research Company (SPARC) has received a Complete Response Letter (CRL) from the USFDA for the New Drug Application (NDA) for Xelpros, Latanoprost BAK-free eyedrops. SPARC had out-licensed Xelpros to a subsidiary of Sun Pharmaceutical Industries in June 2015.

The CRL references the recent inspection of the Sun Pharmaceutical Industries’ Halol manufacturing site by USFDA and indicates that satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Xelpros. There are no requirements of any additional data from USFDA in the CRL.

Sun Pharma Advanced Research Company is an international pharmaceutical company engaged in research and development of drugs and delivery systems.


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