FDA Approval Activities for this Drug
Flolan (epoprostenol sodium) Injection, Glaxo Wellcome NDA 20-444/S-003 4/14/00 4/17/00 4/17/00 1/7/02
Flolan Indication: Long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III & Class IV patients who do not respond to conventional therapy. | FLOLAN (epoprostenol sodium) Injection, GlaxoSmithKline, Labeling Revision | Epoprostenol Sodium Injection, Teva Parenteral, Approval | Epoprostenol Injection, GeneraMedix, Inc., Approval