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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bosutinib
Trade Name: Bosulif
Date Designated: 02/24/2009
Orphan Designation: Treatment of chronic myelogenous leukemia
Orphan Designation Status: Designated/Approved
PF PRISM C.V.
Rivium Westlaan 142
Capelle aan den IJssel 2909 LD
Netherlands

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: bosutinib
Trade Name: Bosulif
Marketing Approval Date: 09/04/2012
Approved Labeled Indication: Treatment of adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy
Exclusivity End Date: 09/04/2019 
Exclusivity Protected Indication* :  
2 Generic Name: bosutinib
Trade Name: Bosulif
Marketing Approval Date: 12/19/2017
Approved Labeled Indication: BOSULIF is indicated for the treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML).
Exclusivity End Date: 12/19/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
3 Generic Name: bosutinib
Trade Name: Bosulif
Marketing Approval Date: 09/26/2023
Approved Labeled Indication: treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy
Exclusivity End Date: 09/26/2030 
Exclusivity Protected Indication* :  treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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