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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: rituximab
Trade Name: Rituxan
Date Designated: 01/29/2004
Orphan Designation: Treatment of chronic lymphocytic leukemia
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1DNA Way
MS 241A
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: rituximab
Trade Name: Rituxan
Marketing Approval Date: 02/18/2010
Approved Labeled Indication: Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide
Exclusivity End Date: 02/18/2017 
Exclusivity Protected Indication* :  

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