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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

Jan 25, 2013Approval FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia
Jan 31, 2012Approval FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer
Dec 22, 2008Approval FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

Further information

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