Search Orphan Drug Designations and Approvals
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Generic Name: | Epoprostenol | ||||||||||||||||
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Trade Name: | Flolan | ||||||||||||||||
Date Designated: | 09/25/1985 | ||||||||||||||||
Orphan Designation: | Treatment of primary pulmonary hypertension. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Epoprostenol |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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