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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
Date Designated: 02/14/2006
Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)
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
Marketing Approval Date: 04/19/2011
Approved Labeled Indication: For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). )
Exclusivity End Date: 04/19/2018 
Exclusivity Protected Indication* :  
2 Generic Name: rituximab
Trade Name: Rituxan
Marketing Approval Date: 09/27/2019
Approved Labeled Indication: RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA)
Exclusivity End Date: 09/27/2026 
Exclusivity Protected Indication* :  indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

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