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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 and recombinant human hyaluronidase
Trade Name: Rituxan SC
Date Designated: 08/22/2016
Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL)
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
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 and recombinant human hyaluronidase
Trade Name: Rituxan SC
Marketing Approval Date: 06/22/2017
Approved Labeled Indication: Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide
Exclusivity End Date: 06/22/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide

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