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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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