TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

VENTOLIN HFA

ALBUTEROL SULFATE
Respiratory Approved 2001-04-19
2
Indications
--
Phase 3 Trials
1
Priority Reviews
24
Years on Market

Details

Status
Prescription
First Approved
2001-04-19
Routes
INHALATION
Dosage Forms
AEROSOL, METERED

Companies

Active Ingredient: ALBUTEROL SULFATE

VENTOLIN HFA Approval History

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What VENTOLIN HFA Treats

3 indications

VENTOLIN HFA is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bronchospasm
  • Obstructive Airway Disease
  • Exercise-Induced Bronchospasm
Source: FDA Label
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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

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.

VENTOLIN HFA FDA Label Details

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Indications & Usage

FDA Label (PDF)

VENTOLIN HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. 1.1 Bronchospasm VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm...

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Data Sources

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