Search Orphan Drug Designations and Approvals
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Generic Name: | tocilizumab | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | tocilizumab |
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Trade Name: | Actemra | |
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. | |
2 | Generic Name: | tocilizumab |
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Trade Name: | Actemra | |
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: | N/A | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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