US FDA reverses NDA nod for Sun Pharma’s anti epileptic drug

SPARC had earlier received a final approval from US FDA in March 2015 for this product

Sun Pharma Advanced Research Company (SPARC) announced that the US Food and Drug Administration (US FDA) has issued a Complete Response letter (CRL) to 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 US FDA in March 2015 for this product and was evaluating several marketing partners for commercialisation. However, SPARC has now received a CRL from the US FDA 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 Ltd (SPIL)’s Halol facility. SPIL is working with US FDA in resolving the cGMP deviations at the facility and has taken several corrective measures.