epoprostenol

FDA Drug Profile — epoprostenol, Veletri

Drug Details

Generic Name
epoprostenol
Brand Names
epoprostenol, Veletri
Application Number
ANDA210473
Sponsor
Sun Pharmaceutical Industries, Inc.
NDC Codes
4
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
EPOPROSTENOL SODIUM, EPOPROSTENOL

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 for injection is a prostacyclin 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 )