Humira FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 25, 2022.
FDA Approved: Yes (First approved December 31, 2002)
Brand name: Humira
Generic name: adalimumab
Dosage form: Injection
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Active, Crohn's Disease, Maintenance, Psoriasis, Juvenile Idiopathic Arthritis, Ulcerative Colitis, Hidradenitis Suppurativa, Uveitis
Humira (adalimumab) is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, hidradenitis suppurativa, and certain types of uveitis.
Development timeline for Humira
|Feb 24, 2021||Approval Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis|
|Mar 30, 2017||Approval FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's Humira (adalimumab) Prescribing Information|
|Jun 30, 2016||Approval AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis|
|Sep 11, 2015||Approval FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa|
|Sep 25, 2014||Approval FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease|
|Sep 28, 2012||Approval FDA Approves Humira to Treat Ulcerative Colitis|
|Feb 22, 2008||Approval Abbott Receives FDA Approval for Humira (Adalimumab) for
Polyarticular Juvenile Idiopathic Arthritis|
|Jan 22, 2008||Approval Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to
Severe Chronic Plaque Psoriasis|
|Feb 27, 2007||Approval Humira (Adalimumab) Receives FDA Approval For Treatment of Crohn'sDisease|
|Jul 31, 2006||Approval Humira Receives FDA Approval for Treatment of Ankylosing Spondylitis|
|Oct 4, 2005||Approval Humira Receives FDA Approval for Psoriatic Arthritis|
|Dec 31, 2002||Approval FDA Approves Humira (adalimumab) for Rheumatoid Arthritis|
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