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Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee

The Committees discussed new drug application (NDA) 209904 for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates grdeater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia. 21 of 24 members, voted that the overall risk-benefit profile of stannsoporfin does not support approval. Three of the 24 members did support approval with a REMS.