Saturday, February 24, 2018
Mallinckrodt plc, a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (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 August 22, 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 need1.
"We are pleased the FDA has accepted our application," said Steve Romano, M.D., Chief Scientific Officer and Executive Vice President of Mallinckrodt. "We look forward to working with the agency in the coming months on the potential approval of stannsoporfin as a new treatment option for thousands of infants at risk for developing severe jaundice who have an unmet medical need."
