• 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: 06/15/2017
Orphan Designation: Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 10/22/2024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
Actelion Pharmaceuticals Ltd. (a Janssen Pharmaceutical Company of Johnson and Johnson)
Gewerbestrasse 16
Allschwil CH-4123
Switzerland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-