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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:  09/07/2016
Orphan Designation:  Treatment of diffuse large B-cell lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/22/2017 
Approved Labeled Indication:  Treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
Exclusivity End Date:    06/22/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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