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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:  09/28/2012
Orphan Designation:  Treatment of anaplastic large cell lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  01/14/2021 
Approved Labeled Indication:  treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity End Date:    01/14/2028 
Exclusivity Protected Indication* :  treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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