Posted by Michael Wonder on 22 Aug 2018
Mallinckrodt confirms receipt of stannsoporfin complete response letter
22 August 2018 - Mallinckrodt confirmed today that it has received a complete response letter from the U.S. FDA related to its new drug application for stannsoporfin.
In the letter, the Agency provided guidance regarding areas of further evaluation for resubmitting the stannsoporfin NDA for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice, or hyperbilirubinemia.
