FDA says Mallinckrodt jaundice candidate not ready for primetime

Mallinckrodt plc (NYSE:MNK) said FDA issued a complete response letter for its NDA for stannsoporfin to treat newborns with at least 35 weeks of gestational age who are at risk of developing hyperbilirubinemia, or severe jaundice.

In May, FDA's Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee voted 21-3 that the risk-benefit profile of stannsoporfin does not support the candidate's approval in the indication...