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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  ambrisentan
Trade Name:  Letairis
Date Designated:  07/16/2004
Orphan Designation:  Treatment of pulmonary arterial hypertension
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/15/2007 
Approved Labeled Indication:  Treatment of pulmonary arterial hypertension (WHO group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening
Exclusivity End Date:    06/15/2014 
Exclusivity Protected Indication* :  
Gilead Colorado
7575 West 103rd Avenue
Suite 102
Westminister, Colorado 80021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.