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 (Approved 10/30/2006)
• Patient Information Sheet
• Regulatory history including approval letters and reviews from Drugs@FDA

Back to Top     Back to Drug Index

PDF requires the free Adobe Acrobat Reader

Date created: January 20, 2004; Updated February 26, 2007

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research