Search Orphan Drug Designations and Approvals
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| Generic Name: | acalabrutinib | ||||||||||||||||
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| Trade Name: | |||||||||||||||||
| Date Designated: | 05/13/2015 | ||||||||||||||||
| Orphan Designation: | Treatment of chronic lymphocytic leukemia (CLL). | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Acerta Pharma, LLC (a member of the AstraZeneca Group) 121 Oyster Point Boulevard 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: | acalabrutinib |
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| Trade Name: | ||
| Marketing Approval Date: | 11/21/2019 | |
| Approved Labeled Indication: | CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | |
| Exclusivity End Date: | 11/21/2026 | |
| Exclusivity Protected Indication* : | Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | |
| 2 | Generic Name: | acalabrutinib |
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| Trade Name: | Calquence | |
| Marketing Approval Date: | 08/04/2022 | |
| Approved Labeled Indication: | Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) | |
| Exclusivity End Date: | TBD | |
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