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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
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.

Marketing approved:

1 Generic Name: ambrisentan
Trade Name: Letairis
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* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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