FDA accepts NDA for stannsoporfin a treatment of neonates at risk for developing severe hyperbilirubinemia.- Mallinckrodt

Mallinckrodt plc announced the FDA has accepted its New Drug Application (NDA) seeking approval of its recently acquired developmental product stannsoporfin. If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set its action date to respond to the NDA as 22 August, 2018. The agency previously granted its Fast Track status to stannsoporfin. The Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.