Data updated: May 26, 2026
SURFAXIN (lucinactant)
Respiratory
Approved 2012-03-06
1
Indication
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-03-06
- Routes
- INTRATRACHEAL
- Dosage Forms
- SUSPENSION
SURFAXIN Approval History
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2012 to 2014
Apr 2014 SUPPL
Mfg · Manufacturing (CMC)
Oct 2013 SUPPL
Mfg · Manufacturing (CMC)
Apr 2013 SUPPL
Mfg · Manufacturing (CMC)
Dec 2012 SUPPL
Mfg
What SURFAXIN Treats
1 FDA approvalsOriginally approved for its first indication in 2012 .
- Other (1)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04389671 results posted | 02-CL-2001a | Ph 2 | completed | The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19) |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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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.
SURFAXIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.