Search Orphan Drug Designations and Approvals
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Generic Name: | imatinib mesylate | ||||||||||||||||
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Trade Name: | Gleevec | ||||||||||||||||
Date Designated: | 11/01/2001 | ||||||||||||||||
Orphan Designation: | Treatment of gastrointestinal stromal tumors | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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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: | 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 |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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