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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop-1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate
Date Designated: 07/22/2019
Orphan Designation: Treatment of fatty acid oxidation disorders
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/08/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Reneo Pharma Ltd
Innovation House, Office 12B
Discovery Park, Ramsgate Road
Sandwich, Kent
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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