Search Orphan Drug Designations and Approvals
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Generic Name: | rituximab | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | rituximab |
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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 |
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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) | |
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