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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  ponatinib
Trade Name:  Iclusig
Date Designated:  11/20/2009
Orphan Designation:  Treatment of chronic myeloid leukemia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/14/2012 
Approved Labeled Indication:  Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Exclusivity End Date:    12/14/2019 
Exclusivity Protected Indication* :  
ARIAD Pharmaceuticals Inc.
26 Landsdowne Steet
Cambridge, Massachusetts 02139
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.