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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 4-hydroxybenzoic acid
Date Designated: 02/15/2026
Orphan Designation: treatment of primary CoQ10 deficiency
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
New York University, on behalf of NYU Grossman School of Medicine
550 First Avenue
New York, New York 10016
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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