XOPENEX HFA (levalbuterol tartrate)
Xopenex HFA is an inhaled medication used to manage or prevent bronchospasm in adults and children four years of age and older. It helps patients with reversible obstructive airway disease by relaxing the muscles in the lungs to make breathing easier. This medication is prescribed to both address active airway constriction and protect against future episodes.
How XOPENEX HFA Works
Levalbuterol acts as a functional antagonist by activating beta 2-adrenergic receptors on airway smooth muscle. This activation stimulates adenylate cyclase, increasing intracellular cyclic AMP levels. The rise in cyclic AMP activates protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation from the trachea to the terminal bronchioles. Additionally, increased cyclic AMP levels inhibit the release of mediators from mast cells in the airway, providing protection against various bronchoconstrictor challenges.
Details
- Status
- Prescription
- First Approved
- 2005-03-11
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
XOPENEX HFA Approval History
What XOPENEX HFA Treats
2 indicationsXOPENEX HFA is approved for 2 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
XOPENEX HFA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
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.
XOPENEX HFA FDA Label Details
Indications & Usage
FDA Label (PDF)XOPENEX HFA is indicated for the treatment of Bronchospasm; Obstructive Airway Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.