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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(r); MabThera(r)
Date Designated:  02/23/2015
Orphan Designation:  Treatment of pemphigus vulgaris.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/07/2018 
Approved Labeled Indication:  RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
Exclusivity End Date:    06/07/2025 
Exclusivity Protected Indication* :  RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
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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