FDA Sends Complete Response Letter to Mallinckrodt

Mallinckrodt confirmed it received a complete response letter from the FDA over its new drug application for stannsoporfin, a treatment for newborns at risk of developing severe jaundice.

The drugmaker said that the FDA’s letter was not unexpected after a recent joint meeting of the Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee recommended that the drug’s risk-benefit profile does not support the NDA’s approval.

The company said it would call a meeting with the agency in the coming months to discuss potential next moves.