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SPARC gets orphan drug designation for Phenobarbital but shares decline 5%

The Orphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital, which is used in treating neonatal seizures.

October 07, 2019 / 14:53 IST
     
     
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    Shares of Sun Pharma Advanced Research Company (SPARC) fell 5 percent intraday on October 7 even after the company received orphan drug designation from USFDA for Phenobarbital used in the treatment of patients with neonatal seizures.

    The orphan drug act provides economic incentives to encourage the development of drugs for diseases affecting fewer than 2,00,000 people in the United States.

    The designation will grant seven years of US market exclusivity upon approval of Phenobarbital. Incentives include waiver of user fee by the US Food and Drug Administration and assistance in clinical trial design by the American regulator.

    At 14:30 hours, Sun Pharma Advanced Research Company was quoting at Rs 116.85, down Rs 5.80, or 4.73 percent, on the BSE.

    Moneycontrol News
    first published: Oct 7, 2019 02:53 pm

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