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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
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.

Marketing approved:

1 Generic Name: Imatinib
Trade Name: Gleevec
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* :  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.