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Adalimumab
Product Approval Information - Licensing Action
Proper name: Adalimumab
Tradename: HUMIRA
Manufacturer: Abbott Laboratories, Abbott Park, IL, License #0043
Indication for Use: For reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be used alone or in combination with Methotrexate (MTX) or other DMARDs.
Approval Date: 12/31/2002
Type of submission: Biologics license application
Approval Letter
(Text)
Label
(PDF),
(Text)
Clinical Review -
(Part 1 PDF),
(Part 2 PDF),
(Part 3 PDF),
(Part 4 PDF),
(Part 5 PDF),
(Text)
Chemistry Review
(PDF)
Clinical Pharmacology and Biopharmaceutics Review
(PDF)
Pharmacology Review
(PDF)
Statistical Review
(PDF)
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Date created: September 16, 2003; Updated
January 18, 2005 |
