Search Orphan Drug Designations and Approvals
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Generic Name: | macitentan | ||||||||||||||||
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Trade Name: | Opsumit | ||||||||||||||||
Date Designated: | 09/03/2009 | ||||||||||||||||
Orphan Designation: | Treatment of pulmonary arterial hypertension | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Actelion Pharmaceuticals Ltd Gewerbestrasse 16 Allschwil Switzerland 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: | macitentan |
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Trade Name: | Opsumit | |
Marketing Approval Date: | 10/18/2013 | |
Approved Labeled Indication: | Treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH. | |
Exclusivity End Date: | 10/18/2020 | |
Exclusivity Protected Indication* : | Treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH. | |
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