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Cimzia FDA Approval History

FDA Approved: Yes (First approved April 22, 2008)
Brand name: Cimzia
Generic name: certolizumab pegol
Dosage form: Injection
Company: UCB, Inc.
Treatment for: Crohn's Disease, Acute, Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

Development timeline for Cimzia

Mar 29, 2019Approval FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis
May 28, 2018Approval UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis
Oct 18, 2013Approval Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis
Sep 30, 2013Approval FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis
Jul 24, 2013U.S. FDA Arthritis Advisory Committee Votes On Cimzia (certolizumab pegol) For Treatment of Adults with Active Axial Spondyloarthritis, Including Patients with Ankylosing Spondylitis
May 13, 2009Approval UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
Feb  6, 2009UCB's meeting with U.S. FDA defines path forward for Cimzia in rheumatoid arthritis
Jan  5, 2009UCB Receives Complete Response Letter from U.S. FDA for Use of Cimzia in Rheumatoid Arthritis Patients
Apr 22, 2008Approval Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease
Feb  6, 2008FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid Arthritis
Mar 23, 2007UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US
Mar  2, 2006UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease

Further information

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