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 |
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* : | |
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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