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

    NPPA Revises Retail and Ceiling Prices of 35 Drug Formulations; Fixes Prices of 34 New Drugs, Cholecalciferol, Oxaliplatin and Sun Pharma’s Diclofenac Gel

    New Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has issued four price-related notifications dated November 2, 2026, covering the fixation…

    ED attaches assets, freezes bank account in counterfeit medicines racket; searches five premises in Bengaluru

    During the raid, the accused were allegedly found storing medicines and pharmaceutical drugs without valid licences, permits or authorisations and replacing labels on the stored medicines. The Directorate of Enforcement…

    Leave a Reply

    Your email address will not be published.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

    You Missed

    NPPA Revises Retail and Ceiling Prices of 35 Drug Formulations; Fixes Prices of 34 New Drugs, Cholecalciferol, Oxaliplatin and Sun Pharma’s Diclofenac Gel

    NPPA Revises Retail and Ceiling Prices of 35 Drug Formulations; Fixes Prices of 34 New Drugs, Cholecalciferol, Oxaliplatin and Sun Pharma’s Diclofenac Gel

    ED attaches assets, freezes bank account in counterfeit medicines racket; searches five premises in Bengaluru

    ED attaches assets, freezes bank account in counterfeit medicines racket; searches five premises in Bengaluru

    Hyderabad Startup Working On Personalised Cancer Vaccine: What It Means For Cancer Treatment

    Hyderabad Startup Working On Personalised Cancer Vaccine: What It Means For Cancer Treatment

    Medicines that cure Us are making Our Environment Sick

    Medicines that cure Us are making Our Environment Sick

    ZEN- G packs a punch in Organ Donation as Over 500 Students pledge Organs

    ZEN- G packs a punch in Organ Donation as Over 500 Students pledge Organs

    PGIMS recalls drug amid probe into deaths

    PGIMS recalls drug amid probe into deaths