SPARC gets orphan drug designation for Phenobarbital from US FDA

Sun Pharma Advanced Research Company (SPARC) 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.

Incentives include waiver of user fee by the United States Food and Drug Administration (US FDA) 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.

Shares of Sun Pharma Advanced Research Company closed at Rs 122.65 per scrip on BSE, up 1.32 per cent from its previous close.