NDAINHALATIONAEROSOL, METERED3 Generics Approved
Approved
Apr 2001
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
12
Data completeness
3/8 — Basic
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VENTOLIN HFA (albuterol sulfate) is a metered-dose inhaler containing a short-acting beta-2 adrenergic agonist approved for treatment of bronchospasm and exercise-induced bronchospasm in patients 4 years and older. The drug works by stimulating beta-2 adrenergic receptors in bronchial smooth muscle, increasing cyclic AMP and causing rapid bronchodilation. Albuterol demonstrates onset of action within 5 minutes with peak effect at approximately 1 hour, making it a first-line rescue therapy in asthma management. It remains a foundational component of asthma treatment protocols globally.
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Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
Started Dec 2024
724 enrolled
Asthma
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
Started May 2024
30 enrolled
Asthma
A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma
Started Dec 2023
64 enrolled
Asthma, Exercise-Induced
BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma
Started Dec 2023
120 enrolled
Bronchial Asthma
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Started Aug 2023
2,700 enrolled
Asthma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.