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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
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* :  
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.
 
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
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* :  
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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