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U.S. Department of Health and Human Services

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)
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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