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