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Bosulif Approval History

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

Bosulif (bosutinib) is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML).

Development History and FDA Approval Process for Bosulif

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

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