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    SPARC neonatal seizures drug Phenobarbital gets Orphan Drug Designation from USFDA

    Farhat NasimWritten by Farhat Nasim Published On 2019-10-05T12:00:04+05:30  |  Updated On 2021-08-16T15:36:52+05:30

    Orphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital for the treatment of patients with neonatal seizures, Sun Pharma Advanced Research Company (SPARC) said in a filing to the BSE.


    New Delhi: Sun Pharma Advanced Research Company (SPARC) on Friday said it has received orphan drug designation from the US health regulator for Phenobarbital used for the treatment of patients with neonatal seizures.


    Orphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital for the treatment of patients with neonatal seizures, SPARC said in a filing to the BSE.


    Also Read: Sun Pharma Research Arm- SPARC gets USFDA orphan drug designation for novel kinase inhibitor


    Incentives include a waiver of user fee by the United States Food and Drug Administration (USFDA) and assistance in clinical trial design by the regulator, it added.


    The Orphan Drug Act provides economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States, SPARC said.

    SPARC was demerged from Sun Pharma as a pharma research and drug discovery company in 2007.

    Also Read: Sun Pharma and SPARC's XELPROS gets USFDA approval
    BSE neonatal seizures Orphan Drug Orphan Drug Act orphan drug designation pharma pharma news pharma news india Phenobarbital seizures SPARC Sun Pharma Sun Pharma Advanced Research Company United States Food and Drug Administration US US health regulator USFDA usfda odd 
    Source : with inputs

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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