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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: macitentan
Date Designated: 06/15/2017
Orphan Designation: Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Actelion Clinical Research, Inc.
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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