Search Orphan Drug Designations and Approvals
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| Generic Name: | Imatinib mesylate | ||||||||||||||||
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| Trade Name: | Gleevec | ||||||||||||||||
| Date Designated: | 10/05/2005 | ||||||||||||||||
| Orphan Designation: | Treatment of myeloproliferative disorders/myelodysplastic syndromes associated with platelet-derived growth factor gene re-arrangements | ||||||||||||||||
| 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 myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements | |
| Exclusivity End Date: | 10/19/2013 | |
| Exclusivity Protected Indication* : | ||
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