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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
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
Trade Name: Rituxan(r); MabThera(r)
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.

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