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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
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.