EPOPROSTENOL SODIUM · GLAND
Epoprostenol sodium treats pulmonary arterial hypertension (WHO Group I) to help patients improve their exercise capacity. It is typically used for those with advanced symptoms, specifically NYHA Functional Class III-IV. This medication helps patients whose hypertension is idiopathic, inherited, or associated with connective tissue diseases.
How EPOPROSTENOL SODIUM Works
This drug works by directly dilating the arterial vascular beds in the lungs and throughout the body. It also functions as a prostacyclin that prevents platelets from aggregating. These actions help manage the vascular resistance associated with the condition.
Details
- Status
- Prescription
- First Approved
- 1995-09-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EPOPROSTENOL SODIUM Approval History
What EPOPROSTENOL SODIUM Treats
1 indicationsEPOPROSTENOL SODIUM is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
EPOPROSTENOL SODIUM Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EPOPROSTENOL SODIUM's indications
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Active Pipeline
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Key Completed Trials
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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.
EPOPROSTENOL SODIUM FDA Label Details
Indications & Usage
FLOLAN is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). FLOLAN is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Studies establishing effectiveness included predominantly (97%) patients w...
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Full clinical data, patents, trials, and competitive landscape for epoprostenol sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.