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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 mesylate
Trade Name:  Gleevec
Date Designated:  10/05/2005
Orphan Designation:  Treatment of myeloproliferative disorders/myelodysplastic syndromes associated with platelet-derived growth factor gene re-arrangements
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/19/2006 
Approved Labeled Indication:  Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements
Exclusivity End Date:    10/19/2013 
Exclusivity Protected Indication* :  
Novartis Pharmaceuticals Corporation
One Health Plaza
Mail Code 105/1E870D
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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