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Sun Pharma arm gets USFDA nod for Elepsia XR, an antiepileptic drug


Sun Pharma arm gets USFDA nod for Elepsia XR, an antiepileptic drug

The United States Food and Drug Administration (USFDA) has granted 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 United States Food and Drug Administration (USFDA) has granted 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.

Elepsia XR is a prescription medication used to treats partial onset seizures. Elepsia XR belongs to a group of drugs called anticonvulsants, which may work by decreasing abnormal excitement in the brain. This medication comes as an extended-release tablet and is usually taken once a day.

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.

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.

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