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The FDA approved only the five-mg, twice-daily dose on the grounds that a higher dose was not considered to have an adequate risk-to-benefit ratio. [34] In September 2020, the FDA approved tofacitinib for the treatment of children and adolescents two years of age and older with active polyarticular course juvenile idiopathic arthritis. [35]
The FDA approved opzelura cream this year, to treat vitiligo in adult and pediatric patients 12 years of age and older.
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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
It was approved for medical use in the United States in 2011, [15] and in the European Union in 2012. [8] Ruxolitinib is the first FDA-approved pharmacologic treatment to address repigmentation in vitiligo patients. [16] The crystal structure of ruxolitinib and of its dihydrate form are known. [17]
The FDA approved Pfizer Inc's (PFE) supplemental marketing application seeking approval for Xeljanz (tofacitinib) for active ankylosing spondylitis. The approval covers adult patients who have had ...
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