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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: monoclonal antibody 3F8
Date Designated: 10/16/2008
Orphan Designation: Treatment of neuroblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
United Therapeutics Corporation
55 TW Alexander Drive
P. O. Box 14186
Research Triangle Park, North Carolina 27709
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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