Drug news
Complete Response Letter for stannsoporfin. to treat newborns at risk of developing severe jaundice. Mallinckrodt plc.
Mallinckrodt plc confirmed that it has received a Complete Response Letter from the FDA related to its New Drug Application (NDA) for stannsoporfin. In the letter, the Agency provided guidance regarding areas of further evaluation for resubmitting the stannsoporfin NDA for the treatment of newborns greater than 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice, or hyperbilirubinemia.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.