From USFDA
Sun Pharma Advanced Research Company announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Elepsia XRTM (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 TM is to be manufactured at Sun Pharmaceutical Industries (SPIL)'s Halol facility. SPIL is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.
Powered by Capital Market - Live News
