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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: 09/13/2010
Orphan Designation: Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer
Orphan Designation Status: Designated/Approved
Pfizer, Inc.
66 Hudson Boulevard East
New York, New York 10001
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: 08/26/2011
Approved Labeled Indication: Treatment of patients with locally advanced or metastatic non-small cell lungcancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDAapprovedtest
Exclusivity End Date: 08/26/2018 
Exclusivity Protected Indication* :  
2 Generic Name: crizotinib
Trade Name: Xalkori
Marketing Approval Date: 03/11/2016
Approved Labeled Indication: Treatment of patients with metastatic NSCLC whose tumors are ROS1-positive
Exclusivity End Date: 03/11/2023 
Exclusivity Protected Indication* :  Treatment of patients with metastatic NSCLC whose tumors are ROS1-positive
3 Generic Name: crizotinib
Trade Name: Xalkori
Marketing Approval Date: 09/07/2023
Approved Labeled Indication: treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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