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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Epoprostenol
Trade Name: Flolan
Date Designated: 09/25/1985
Orphan Designation: Treatment of primary pulmonary hypertension.
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park, North Carolina 27709
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Epoprostenol
Trade Name: Flolan
Marketing Approval Date: 09/20/1995
Approved Labeled Indication: Long-term intravenous treatment of primary pulmonary hypertension in NYHA Class III and Class IV patients.
Exclusivity End Date: 09/20/2002 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.