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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Rilpivirine oral suspension
Date Designated: 01/19/2022
Orphan Designation: Treatment of Neuroblastoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 07/09/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aptorum International Limited
4T.07 17 Hanover Square
London, not applicable W1S 1BN
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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