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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:  07/31/2012
Orphan Designation:  Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/11/2018 
Approved Labeled Indication:  ACTEMRA® (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity End Date:     
Exclusivity Protected Indication* :  
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  tocilizumab
Trade Name:  Actemra
Date Designated:  07/31/2012
Orphan Designation:  Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/29/2013 
Approved Labeled Indication:  ACTEMRA® (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity End Date:    04/29/2020 
Exclusivity Protected Indication* :  Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Genentech, Inc.
1 DNA Way
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.
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