Search Orphan Drug Designations and Approvals
-
| 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* : | |
| 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. |
| 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* : | |
| 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. |
-
