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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.

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