Drug Information

Gleevec (Imatinib Mesylate) 

Gleevec is approved to treat a rare cancer called Chronic Myeloid Leukemia (CML),

• FDA grants Gleevec regular approval as a second line treatment for refractory Chronic Myeloid Leukemia. FDA News (12/8/2003)
• FDA News Release (5/10/2001)
• Questions and Answers (5/11/2001)
• Revised Product Label (12/8/2003)
• Approval Letter (12/8/2003)
• Product Label (5/11/2001)
• Approval Letter (5/11/2001)

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FDA/Center for Drug Evaluation and Research
Last Updated: January 20, 2004
Originator: OTCOM/DLIS
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