SPARC receives US FDA orphan drug designation for Phenobarbital
Sun Pharma Advanced Research Company (SPARC) said that US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Phenobarbital for 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 200,000 people in the United States, SPARC said.
Orphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital for the treatment of patients with neonatal seizures, the company said.
Incentives include waiver of user fee by US FDA and assistance in clinical trial design by US FDA.