Search Orphan Drug Designations and Approvals
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| Generic Name: | rituximab | ||||||||||||||||
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| Trade Name: | Rituxan | ||||||||||||||||
| Date Designated: | 06/13/1994 | ||||||||||||||||
| Orphan Designation: | Treatment of non-Hodgkin's B-cell lymphoma | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Genentech, Inc. 1 DNA Way, MS 242 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: | 11/26/1997 | |
| Approved Labeled Indication: | Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma | |
| Exclusivity End Date: | 11/26/2004 | |
| Exclusivity Protected Indication* : | ||
| 2 | Generic Name: | rituximab |
|---|---|---|
| Trade Name: | Rituxan | |
| Marketing Approval Date: | 12/02/2021 | |
| Approved Labeled Indication: | treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy | |
| Exclusivity End Date: | 12/02/2028 | |
| Exclusivity Protected Indication* : | treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) | |
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