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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
GlaxoSmithKline
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.
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