Search Orphan Drug Designations and Approvals
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| Generic Name: | asciminib |
|---|---|
| Trade Name: | Scemblix |
| Date Designated: | 02/27/2017 |
| Orphan Designation: | Treatment of chronic myelogenous leukemia |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 10/29/2021 |
| Approved Labeled Indication: | Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) |
| Exclusivity End Date: | 10/29/2028 |
| Exclusivity Protected Indication* : | Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) |
| Sponsor: |
Novartis Pharmaceutical Corporation One Health Plaza East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
| Generic Name: | asciminib |
| Trade Name: | Scemblix |
| Date Designated: | 02/27/2017 |
| Orphan Designation: | Treatment of chronic myelogenous leukemia |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 10/29/2021 |
| Approved Labeled Indication: | Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation |
| Exclusivity End Date: | 10/29/2028 |
| Exclusivity Protected Indication* : | Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation |
| Sponsor: |
Novartis Pharmaceutical Corporation One Health Plaza East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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