SPARC neonatal seizures drug Phenobarbital gets Orphan Drug Designation from USFDA

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.

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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.

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