calfactant

FDA Drug Profile — INFASURF

Drug Details

Generic Name
calfactant
Brand Names
INFASURF
Application Number
BLA020521
Sponsor
ONY Biotech Inc.
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
ENDOTRACHEAL
Active Ingredients
CALFACTANT

Indications and Usage

1 INDICATIONS AND USAGE INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. (1) for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. (1)