Sun Pharma arm gets USFDA nod for epilepsy drug

Sun Pharmaceutical Industries on Friday 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 (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 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 shares settled at Rs 424.75 a piece, down 1.05 per cent on BSE.

  • Related Posts

    Pharma exports rose 2% to over $31 billion in FY26 despite sharp decline in March

    India’s pharmaceutical exports rose more than 2% year on year to $31.11 billion in FY26 despite a 23% decline in March amid the fallout of the West Asia war. A…

    Centre Urges States To Enforce Clinical Establishments Act & Standardise Hospital Rates

    New Delhi — In a significant move to bring greater transparency and accountability in healthcare delivery, the Centre has directed all states and Union Territories to tighten regulatory oversight within…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Pharma exports rose 2% to over $31 billion in FY26 despite sharp decline in March

    Pharma exports rose 2% to over $31 billion in FY26 despite sharp decline in March

    Centre Urges States To Enforce Clinical Establishments Act & Standardise Hospital Rates

    Centre Urges States To Enforce Clinical Establishments Act & Standardise Hospital Rates

    Piramal, Ajinomoto team on ADC development and manufacturing

    Piramal, Ajinomoto team on ADC development and manufacturing

    Aurobindo Pharma Gets USFDA Nod for Glycerol Liquid

    Aurobindo Pharma Gets USFDA Nod for Glycerol Liquid

    Cancer cure must not be hostage to Big Pharma

    Cancer cure must not be hostage to Big Pharma

    GLP-1 drugs emerge as a new option for Indian women bat­tling PCOS

    GLP-1 drugs emerge as a new option for Indian women bat­tling PCOS