epoprostenol sodium
Drug Details
- Generic Name
- epoprostenol sodium
- Brand Names
- FLOLAN
- Application Number
- NDA020444
- Sponsor
- GlaxoSmithKline LLC
- NDC Codes
- 1
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- EPOPROSTENOL SODIUM
Indications and Usage
1 INDICATIONS AND 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 with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). ( 1 )