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

    WHO launches new primary health care course to strengthen health systems globally

    Health is a human right – yet not everyone can access the health services they need, when and where they need them, without financial hardship. Primary health care (PHC) provides…

    Ayurveda needs stronger evidence, safety monitoring for market adoption, says CCRAS

    Bengaluru: The Central Council for Research in Ayurvedic Sciences (CCRAS) has called for stronger scientific evidence, safety monitoring and translation of research into market-ready technologies to improve the credibility and…

    Leave a Reply

    Your email address will not be published.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

    You Missed

    WHO launches new primary health care course to strengthen health systems globally

    WHO launches new primary health care course to strengthen health systems globally

    Ayurveda needs stronger evidence, safety monitoring for market adoption, says CCRAS

    Ayurveda needs stronger evidence, safety monitoring for market adoption, says CCRAS

    Yashoda Medicity Successfully Performs High-Risk Kidney Transplant in 28-Year- Old Woman

    Yashoda Medicity Successfully Performs High-Risk Kidney Transplant in 28-Year- Old Woman

    Avacta delivers two clinical stage peptide-drug conjugates to target delivery of toxic payloads into the tumour microenvironment

    Avacta delivers two clinical stage peptide-drug conjugates to target delivery of toxic payloads into the tumour microenvironment

    US FDA approves first gene therapy for paediatric patients with Sanfilippo syndrome type A

    US FDA approves first gene therapy for paediatric patients with Sanfilippo syndrome type A

    Technology and accessibility are key to growth of advanced treatment of heart diseases, says expert

    Technology and accessibility are key to growth of advanced treatment of heart diseases, says expert