Actemra Approval History

• FDA approved: Yes (First approved January 8th, 2010)
• Brand name: Actemra
• Generic name: tocilizumab
• Company: Genentech USA, Inc.
• Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis

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

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

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Actemra (tocilizumab) Consumer Information

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