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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Tositumomab and iodine I 131 tositumomab
Trade Name: Bexxar
Date Designated: 05/16/1994
Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma.
Orphan Designation Status: Designated/Approved
GlaxoSmithKline LLC
Corporation Service Company
2711 Centerville Road, Suite 400
Wilmington, Delaware 19808
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Tositumomab and iodine I 131 tositumomab
Trade Name: Bexxar
Marketing Approval Date: 06/27/2003
Approved Labeled Indication: Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy
Exclusivity End Date: 06/27/2010 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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