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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Anti-tenascin 81C6 monoclonal antibody labeled w/ I 131
Date Designated: 10/04/2005
Orphan Designation: Treatment of primary malignant brain tumors
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bradmer Pharmaceuticals, Inc.
9900 Corporate Campus Drive
Suite 3000
Louisville, Kentucky 40223
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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