Search Orphan Drug Designations and Approvals
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Generic Name: | epoprostenol | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | epoprostenol |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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