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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: 11/01/2001
Orphan Designation: Treatment of gastrointestinal stromal tumors
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
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.

Marketing approved:

1 Generic Name: imatinib mesylate
Trade Name: Gleevec
Marketing Approval Date: 02/01/2002
Approved Labeled Indication: Treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)
Exclusivity End Date: 02/01/2009 
Exclusivity Protected Indication* :  
2 Generic Name: imatinib mesylate
Trade Name: Gleevec
Marketing Approval Date: 12/19/2008
Approved Labeled Indication: Adjuvant treatment of adult patients following complete resection Kit (CD 117) positive gastrointestinal stromal tumors (GIST).
Exclusivity End Date: 12/19/2015 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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