Search Orphan Drug Designations and Approvals
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| Generic Name: | Imatinib |
|---|---|
| Trade Name: | Gleevec |
| Date Designated: | 01/31/2001 |
| Orphan Designation: | Treatment of chronic myelogenous leukemia |
| Orphan Designation Status: | Designated/Approved |
| 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* : | |
| 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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