SPARC receives Complete Response Letter from USFDA for ‘Elepsia XR’

20 May 2017 Evaluate

Sun Pharma Advanced Research Company (SPARC) has received a Complete Response Letter (CRL) from the USFDA for its New Drug Application (NDA) for Elepsia XR, Levetiracetam extended-release tablets 1000 mg and 1500 mg.

The CRL references the recent inspection of the Sun Pharmaceutical Industries’ (SPIL) Halol manufacturing site by USFDA and indicates that, satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XR can be granted.

SPARC had out-licensed Elepsia XR to a subsidiary of Sun Pharmaceutical Industries in July 2016. SPIL is working with USFDA for resolving the cGMP deviations at the Halol facility and has taken several corrective measures.

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



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