Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: crizotinib
Trade Name: Xalkori
Date Designated: 09/28/2012
Orphan Designation: Treatment of anaplastic large cell lymphoma
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: 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.
2 Generic Name: crizotinib
Trade Name: Xalkori
Marketing Approval Date: 09/07/2023
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: 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-