Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: asciminib
Trade Name: Scemblix
Date Designated: 02/27/2017
Orphan Designation: Treatment of chronic myelogenous leukemia
Orphan Designation Status: Designated/Approved
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
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)
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-