Search Orphan Drug Designations and Approvals
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Generic Name: | Imatinib mesylate | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Imatinib mesylate |
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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* : | ||
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