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.
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.