Search Orphan Drug Designations and Approvals
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| Generic Name: | rituximab | ||||||||||||||||
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| Trade Name: | Rituxan | ||||||||||||||||
| Date Designated: | 01/29/2004 | ||||||||||||||||
| Orphan Designation: | Treatment of chronic lymphocytic leukemia | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Genentech, Inc. 1DNA Way MS 241A 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: | 02/18/2010 | |
| Approved Labeled Indication: | Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide | |
| Exclusivity End Date: | 02/18/2017 | |
| Exclusivity Protected Indication* : | ||
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