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Bosulif FDA Approval History

FDA Approved: Yes (First approved September 4, 2012)
Brand name: Bosulif
Generic name: bosutinib
Dosage form: Tablets and Capsules
Company: Pfizer Inc.
Treatment for: Chronic Myelogenous Leukemia

Bosulif (bosutinib) is a kinase inhibitor for use in the treatment of chronic myelogenous leukemia (CML).

Development timeline for Bosulif

DateArticle
Sep 27, 2023Approval FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia
Dec 19, 2017Approval FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)
Sep  4, 2012Approval FDA Approves Bosulif for Chronic Myelogenous Leukemia
Jan 30, 2012Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph+ Chronic Myeloid Leukemia

Further information

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