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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, North Carolina 27709

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