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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Imatinib
Trade Name:  Gleevec
Date Designated:  01/31/2001
Orphan Designation:  Treatment of chronic myelogenous leukemia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/10/2001 
Approved Labeled Indication:  Treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
Exclusivity End Date:    05/10/2008 
Exclusivity Protected Indication* :  
Novartis Pharmaceuticals Corporation
59 Route 10
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.