Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: macitentan
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Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 10/22/2024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
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-