Pediatric committee closed session
Executive Summary
Anti-Infective Drugs Pediatric Subcommittee is understood to have considered safety issues related to WellSpring's tin mesoporphyrin (SnMP, stannsoporfin) during a closed session June 12. An NDA filing for hyperbilirubinemia prevention in infants at risk of developing jaundice is expected by first quarter 2004. Pediatric safety data for other investigational products was also discussed...