Data updated: May 26, 2026
HELIUM, USP (helium)
Respiratory
Approved 2013-07-14
14
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-07-14
- Routes
- INHALATION
- Dosage Forms
- GAS
Companies
AIR PRODUCTS AND CHEMICALS INC PRAXAIR DISTRIBUTION INC A-OX WELDING SUPPLY CO, INC. NORCO INC NEXAIR LLC ROBERTS OXYGEN CO INC ILMO Products Company AIR LIQUIDE HEALTHCARE AMERICA CORP MATHESON TRI-GAS INC AIRGAS USA LLC A G L WELDING SUPPLY CO INC LINDE GAS NORTH AMERICA LLC GENERAL AIR SERVICE & SUPPLY COMPANY PRAXAIR INC PRAXAIR DISTRIBUTION MID-ATLANTIC LLC WESTAIR GASES & EQUIPMENT INC
Active Ingredient: HELIUM
Website: ↗
HELIUM, USP Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2013 to 2021
Sep 2013 ORIGINAL
Update
What HELIUM, USP Treats
14 FDA approvalsOriginally approved for its first indication in 2013 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Aug 2013)Letter
- • Approved indication (Sep 2013)
- • Approved indication (Mar 2014)Letter
- • Approved indication (Feb 2016)Letter
- • Approved indication (Apr 2018)Letter
- • Approved indication (Oct 2018)Letter
- • Approved indication (Jul 2019)Letter
- • Approved indication (Aug 2019)Letter
- • Approved indication (Oct 2019)Letter
- • Approved indication (Jun 2020)Letter
- • Approved indication (Jul 2021)Letter
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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.
HELIUM, USP FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.