epoprostenol

FDA Drug Profile — Veletri, epoprostenol

epoprostenol is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Veletri, epoprostenol. Available dosage form: injection, powder, lyophilized, for solution.

Drug Details

Generic Name
epoprostenol
Brand Names
Veletri, epoprostenol
Application Number
NDA022260
Sponsor
Actelion Pharmaceuticals US, Inc.
NDC Codes
4
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
EPOPROSTENOL, EPOPROSTENOL SODIUM

Indications and Usage

1 INDICATIONS AND USAGE Epoprostenol for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. Epoprostenol sodium is a prostanoid vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. (1)