INFASURF PRESERVATIVE FREE
Details
- Status
- Prescription
- First Approved
- 1998-07-01
- Routes
- INTRATRACHEAL
- Dosage Forms
- SUSPENSION
INFASURF PRESERVATIVE FREE Approval History
What INFASURF PRESERVATIVE FREE Treats
1 indicationsINFASURF PRESERVATIVE FREE is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Respiratory Distress Syndrome
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INFASURF PRESERVATIVE FREE FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.