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Actemra Approval History

FDA Approved: Yes (First approved January 8, 2010)
Brand name: Actemra
Generic name: tocilizumab
Dosage form: Injection
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Giant Cell Arteritis

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; and CAR T cell-induced severe or life-threatening cytokine release syndrome.

Development History and FDA Approval Process for Actemra

DateArticle
Nov 26, 2018Approval FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector
Sep 13, 2018Approval FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)
May 14, 2018Approval FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
Aug 31, 2017Approval FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
May 22, 2017Approval FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis
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 theTreatment of Rheumatoid Arthritis

Further information

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