Sun Pharma Advanced Research Company Ltd. (SPARC), a wholly owned subsidiary of Sun Pharmaceutical Industries, has received the US Food and Drug Administration (FDA) approval for its New Drug Application (NDA) for Elepsia XR (levetiracetam extended-release tablets 1000 mg and 1500 mg).
Elepsia XR is indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.
“Levetiracetam is a very successful and highly effective antiepileptic drug but more than 80% of epilepsy patients require levetiracetam in does in range of 1000mg to 3000mg resulting in a significant pill burden. Approval of Elepsia XR as 1000mg and 1500mg once a day tablets will be very useful for these patients and physicians.” said Anil Raghavan, chief executive officer of SPARC.
The product will be manufactured by Sun Pharmaceutical Industries Ltd at its Halol (Gujarat) facility in India.
Elepsia XR is a novel extended release formulation of levetiracetam 1000 mg and 1500 mg. 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.