Search Orphan Drug Designations and Approvals
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| Generic Name: | zanubrutinib | ||||||||||||||||
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| Trade Name: | Brukinsa | ||||||||||||||||
| Date Designated: | 07/20/2016 | ||||||||||||||||
| Orphan Designation: | Treatment of chronic lymphocytic leukemia | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
BeiGene USA, Inc. 1840 Gateway Drive, 3rd floor San Mateo, California 94404 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: | zanubrutinib |
|---|---|---|
| Trade Name: | Brukinsa | |
| Marketing Approval Date: | 01/19/2023 | |
| Approved Labeled Indication: | treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) | |
| Exclusivity End Date: | 01/19/2030 | |
| Exclusivity Protected Indication* : | treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) | |
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