Search Orphan Drug Designations and Approvals
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Generic Name: | macitentan |
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Date Designated: | 06/06/2017 |
Orphan Designation: | Treatment of Fontan-Palliated patients |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 10/22/2024 |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Janssen Research & Development, LLC 1820 Chapel Avenue West Suite 300 Cherry Hill, New Jersey 08002 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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