Actemra Approval History

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults, and the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.

FDA Approval History for Actemra

DateArticle
Oct 22, 2013Approval Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis
Apr 30, 2013Approval FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
Apr 17, 2011Approval FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)
Jan  5, 2011Approval FDA Grants Supplemental Approval for Actemra (tocilizumab)
Jan 11, 2010Approval FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
Dec  4, 2008Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)
Sep 18, 2008FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application
Jul 29, 2008FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
Nov 21, 2007Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis

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