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 |
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* : | |
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. |
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. |
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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