Search Orphan Drug Designations and Approvals
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| Generic Name: | Imatinib | ||||||||||||||||
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| Trade Name: | Gleevec | ||||||||||||||||
| Date Designated: | 01/31/2001 | ||||||||||||||||
| Orphan Designation: | Treatment of chronic myelogenous leukemia | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Novartis Pharmaceuticals Corporation 59 Route 10 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 |
|---|---|---|
| Trade Name: | Gleevec | |
| Marketing Approval Date: | 05/10/2001 | |
| Approved Labeled Indication: | Treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy | |
| Exclusivity End Date: | 05/10/2008 | |
| Exclusivity Protected Indication* : | ||
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