Sun Pharma Advanced Research Company Ltd. (SPARC) has received Complete Response letter (CRL) from US FDA 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 USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.
Elepsia XR is a novel extended release formulation of Levetiracetam 1000mg and 1500mg. Elepsia XR has been developed with SPARC’s proprietary Wrap Matrix platform technology.
Levetiracetam is an antiepileptic drug (AED) indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.