• 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:  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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-