What is EXOSURF NEONATAL used for?

EXOSURF NEONATAL is an FDA-approved medication. See full prescribing information for approved uses.

Is EXOSURF NEONATAL FDA approved?

Yes, EXOSURF NEONATAL is FDA approved (first approved 1990-08-02) and manufactured by GSK.

Who makes EXOSURF NEONATAL?

EXOSURF NEONATAL is manufactured by GSK.

Data updated: Mar 10, 2026

EXOSURF NEONATAL

CETYL ALCOHOL

Approved 1990-08-02

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Priority Reviews

Years on Market

Details

Status: Discontinued
First Approved: 1990-08-02
Routes: INTRATRACHEAL
Dosage Forms: FOR SUSPENSION

Companies

GSK

Active Ingredient: CETYL ALCOHOL , COLFOSCERIL PALMITATE , TYLOXAPOL

EXOSURF NEONATAL Approval History

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What EXOSURF NEONATAL Treats

1 FDA approvals

Originally approved for its first indication in 1990 .

Other (1)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

EXOSURF NEONATAL FDA Label Details

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Data Sources

FDA Approval: NDA020044 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.