SPARC gets Complete Response letter from USFDA for Elepsia XR

26 Sep 2015 Evaluate

Sun Pharma Advanced Research Company (SPARC) has received Complete Response letter (CRL) form the U.S. Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg).

SPARC had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization. However SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval.

Elepsia XR is to be manufactured at Sun Pharmaceutical Industries' (SPIL) Halol facility. SPIL is working with USFDA in resolving the cGMP deviations at the 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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