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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:treprostinil
Trade Name:Remodulin
Date Designated: 06-04-1997
Orphan Designation:Treatment of pulmonary arterial hypertension.
Orphan Designation Status: Designated/Approved
FDA Orphan Approval Status:Approved for Orphan Indication
Approved Labeled Indication:Treatment of pulmonary arterial hypertension. 
Marketing Approval Date: 05-21-2002
Exclusivity End Date: 05-21-2009
United Therapeutics Corp.
55 T.W. Alexander Dr.
Research Triangle Park, NC 27709

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