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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: humanized anti-GD2 monoclonal antibody
Date Designated: 04/08/2024
Orphan Designation: Treatment of Neuroblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Renaissance Pharma, Ltd.
3rd Floor Ashley Road
Altrincham, Cheshire WA142DT
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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