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