Gleevec FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 25, 2021.
FDA Approved: Yes (First approved May 10, 2001)
Brand name: Gleevec
Generic name: imatinib mesylate
Dosage form: Tablets
Company: Novartis AG
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Diseases, Dermatofibrosarcoma Protuberans, Gastrointestinal Stromal Tumor, Systemic Mastocytosis, Hypereosinophilic Syndrome
Gleevec (imatinib mesylate) is a kinase inhibitor indicated for the treatment of chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic/ myeloproliferative diseases, systemic mastocytosis, hypereosinophilic syndrome, dermatofibrosarcoma protuberans and gastrointestinal stromal tumors.
Development timeline for Gleevec
| Date | Article |
|---|---|
| Jan 25, 2013 | Approval FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia |
| Jan 31, 2012 | Approval FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer |
| Dec 22, 2008 | Approval FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer |
Further information
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