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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 follicular lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/22/2017 
Approved Labeled Indication:   Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
Exclusivity End Date:    06/22/2024 
Exclusivity Protected Indication* :   Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therap; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
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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