Search Orphan Drug Designations and Approvals
-
Generic Name: | asciminib | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trade Name: | Scemblix | ||||||||||||||||
Date Designated: | 02/27/2017 | ||||||||||||||||
Orphan Designation: | Treatment of chronic myelogenous leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
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. |
||||||||||||||||
Marketing approved: |
|||||||||||||||||
1 | Generic Name: | asciminib |
---|---|---|
Trade Name: | Scemblix | |
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 | |
Generic Name: | asciminib | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trade Name: | Scemblix | ||||||||||||||||
Date Designated: | 02/27/2017 | ||||||||||||||||
Orphan Designation: | Treatment of chronic myelogenous leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
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. |
||||||||||||||||
Marketing approved: |
|||||||||||||||||
1 | Generic Name: | asciminib |
---|---|---|
Trade Name: | Scemblix | |
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) | |
-