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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, 2021Approval Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis
Mar 30, 2017Approval FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's Humira (adalimumab) Prescribing Information
Jun 30, 2016Approval AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis
Sep 11, 2015Approval FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa
Sep 25, 2014Approval FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease
Sep 28, 2012Approval FDA Approves Humira to Treat Ulcerative Colitis
Feb 22, 2008Approval Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
Jan 22, 2008Approval Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
Feb 27, 2007Approval Humira (Adalimumab) Receives FDA Approval For Treatment of Crohn'sDisease
Jul 31, 2006Approval Humira Receives FDA Approval for Treatment of Ankylosing Spondylitis
Oct  4, 2005Approval Humira Receives FDA Approval for Psoriatic Arthritis
Dec 31, 2002Approval FDA Approves Humira (adalimumab) for Rheumatoid Arthritis

Further information

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