Search Orphan Drug Designations and Approvals
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| Generic Name: | ambrisentan | ||||||||||||||||
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| Trade Name: | Letairis | ||||||||||||||||
| Date Designated: | 07/16/2004 | ||||||||||||||||
| Orphan Designation: | Treatment of pulmonary arterial hypertension | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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* : | ||
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