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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: 03/22/1999
Orphan Designation: Treatment of secondary pulmonary hypertension due to intrinsic precapillary pulmonary vascular disease.
Orphan Designation Status: Designated/Approved
2301 Renaissance Blvd
P. O. Box 61540
King of Prussia, Pennsylvania 19406
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: 04/14/2000
Approved Labeled Indication: treatment of pulmonary arterial hypertension (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.
Exclusivity End Date: 04/14/2007 
Exclusivity Protected Indication* :  

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