FDA Approvals Calendar
Found 25 Results
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.
May 3, 2018 12:00AM - May 3, 2018 12:00AM
Committee: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee
Indication: 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.
Drug/Device: stannsoporfin injection, for intramuscular use
Sponsor: InfaCare Pharmaceutical Corporation