Sun Pharma Advanced Research Company (SPARC) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for ELEPSIA XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg). ELE PSIA 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 XRTM 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 at its Halol (Gujarat) facility in India.

Shares of the company gained Rs 18.8, or 4.57%, to trade at Rs 430.55. The total volume of shares traded was 333,726 at the BSE (10.09 a.m., Wednesday).