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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tocilizumab
Trade Name: Actemra
Date Designated: 08/01/2017
Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome
Orphan Designation Status: Designated/Approved
Genentech Inc., a member of the Roche Group
1 DNA Way
MS #355e
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: tocilizumab
Trade Name: Actemra
Marketing Approval Date: 08/30/2017
Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity End Date: 08/30/2024 
Exclusivity Protected Indication* :  Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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