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🏅 FDA Orphan Designation

Infasurf

calfactant

Manufacturer: ONY Biotech Inc.

Indicated for:
Neonatal acute respiratory distress syndromeOrphanInfant acute respiratory distress syndrome

FDA-Approved Indications (2)

Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.

to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS

Population: preterm neonates <29 weeks gestational age

Indications & 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)

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Infasurf
ONY Biotech Inc.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.