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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant humanized monoclonal antibody directed against an epidermal growth factor receptor
Date Designated: 02/17/2012
Orphan Designation: Treatment of glioblastoma multiforme
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/25/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AbbVie, Inc.
1 N. Waukegan Road
North Chicago, Illinois 60064
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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