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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
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
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.
 
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
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* :  
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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