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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: 09/09/2005
Orphan Designation: Treatment of systemic mastocytosis without the D816V c-kit mutation
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: Imatinib mesylate
Trade Name: Gleevec
Marketing Approval Date: 10/19/2006
Approved Labeled Indication: Treatment of adult patients with aggressive mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown
Exclusivity End Date: 10/19/2013 
Exclusivity Protected Indication* :  

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