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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ibritumomab tiuxetan
Trade Name: Zevalin
Date Designated: 09/06/1994
Orphan Designation: Treatment of B-cell non-Hodgkin's lymphoma.
Orphan Designation Status: Designated/Approved
Acrotech Biopharma LLC
279 Princeton Hightstown Road
East Windsor, New Jersey 08520
United States

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

Marketing approved:

1 Generic Name: ibritumomab tiuxetan
Trade Name: Zevalin
Marketing Approval Date: 02/19/2002
Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma
Exclusivity End Date: 02/19/2009 
Exclusivity Protected Indication* :  

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