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poractant alfa

FDA Drug Profile — Curosurf

Drug Details

Generic Name
poractant alfa
Brand Names
Curosurf
Application Number
BLA020744
Sponsor
Chiesi USA, Inc.
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
ENDOTRACHEAL
Active Ingredients
PORACTANT ALFA

Indications and Usage

1 INDICATIONS AND USAGE CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants. ( 1 )