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Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee

The Committees will discuss new drug application (NDA) 209904 for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.