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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: crizotinib
Trade Name: Xalkori
Date Designated: 12/20/2021
Orphan Designation: Treatment of inflammatory myofibroblastic tumor
Orphan Designation Status: Designated/Approved
Pfizer Inc.
10646 Science Center Drive
San Diego, California 92121
United States

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

Marketing approved:

1 Generic Name: crizotinib
Trade Name: Xalkori
Marketing Approval Date: 07/14/2022
Approved Labeled Indication: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive
Exclusivity End Date: 07/14/2029 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive
2 Generic Name: crizotinib
Trade Name: Xalkori
Marketing Approval Date: 09/07/2023
Approved Labeled Indication: treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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