The product was filed from Sun Pharma’s Halol (Gujarat) facility
Sun Pharmaceutical Industries said one of its subsidiaries has received approval from the US health regulator to market Elepsia XR, an antiepileptic drug. The United States Food and Drug Administration (US FDA) has gr anted approval for the New Drug Application to a wholly-owned subsidiary of Sun Pharma for Elepsia XR in the strengths of 1,000 mg and 1,500 mg, the company said in a regulatory filing. The product was filed from Sun Pharma’s Halol (Gujarat) facility, it added. The subsidiary concerned had in-licensed Elepsia XR from Sun Pharma Advanced Research Company (SPARC) in July 2016.