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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-{4-[(9R)-9-Hydroxy-2-(3-hydroxy-3-methylbutyloxy)-9-(trifluoromethyl)-9H-fluoren-4-yl]-1H-pyrazol-1-yl}-2-methylpropanamide monohydrate
Date Designated: 01/23/2018
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Akros Pharma Inc.
302 Carnegie Center
Suite 300
Princeton, New Jersey 08540
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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