NEW DELHI: Sun Pharma Advanced Research Company has received approval from the U.S. health regulator for its New Drug Application (NDA) for ELEPSIA XR tablets U.S.ed for treatment of partial onset seizures in patients with epilepsy.
"The U.S. Food and Drug Administration (FDA) has approved New Drug Application (NDA) for ELEPSIA XRTM (Levetiracetam extended-release tablets 1,000 mg and 1,500 mg)," Sun Pharma Advanced Research Company (SPARC) said in a statement.
ELEPSIA XR is indicated for adjunctive therapy in the treatment of partial onset seizures in patients of 12 years of age and older with epilepsy, it added.
Commenting on the development, SPARC CEO Anil Raghavan said: "Levetiracetam is a very successful and highly effective antiepileptic drug but more than 80% of epilepsy patients require Levetiracetam in doses in range of 1,000 mg to 3,000 mg, resulting in a significant pill burden.
"Approval of ELEPSIA XRTM as 1,000 mg and 1,500 mg once a day tablets will be very useful for these patients and physicians."
The product will be manufactured by Sun Pharmaceutical Industries at its Halol facility in Gujarat, SPARC said.
Sun Pharma Advanced Research Company shares were trading 7.01 per cent up at Rs 440.60 per scrip during afternoon trade on the BSE.
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