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# Mallinckrodt NDA for Neonate Drug Under Review
- URL: https://www.fdaweb.com/mallinckrodt-nda-for-neonate-drug-under-review/
- Published: 2018-02-23T12:00:00.000Z
- Updated: 2026-09-14T23:24:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140837

FDA has accepted for review a Mallinckrodt NDA for stannsoporfin, indicated for treating neonates at risk for developing severe hyperbilirubinemia, or severe jaundice. Stannsoporfin is a heme oxygenase inhibitor under investigation for its potential to reduce the production of bilirubin in at-risk infants. FDA has set a user fee review action target date of 8/22\. While neonatal jaundice is a common condition and typically does not require treatment; however, elevated bilirubin levels in the blood (hyperbilirubinemia) can be toxic and may potentially lead to neurologic complications, including encephalopathy or irreversible brain damage, the company says. Currently, phototherapy is used to help the body clear bilirubin and bring levels down. The safety and effectiveness of stannsoporfin have not yet been established by FDA.