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From the Food and Drug Administration
February 14, 2001

New Treament for Eczema

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JAMA. 2001;285(6):724. doi:10.1001/jama.285.6.724

The FDA has approved tacrolimus ointment (Protopic; Fujisawa Healthcare, Deerfield, Ill) for short-term and intermittent long-term therapy for patients with moderate to severe atopic dermatitis in whom the use of coventional therapies is inadvisable or not adequately effective.The indication is for 0.03% and 0.1% tacrolimus for adults and 0.03% for children 2 to 15 years.

The FDA approval was based on results of three randomized, vehicle-controlled, 12-week studies and two 1-year studies with patients with moderate to severe eczema who were not refractory to other treatment. One of the 12-week studies included 351 patients 2-15 years of age, and the other two included a total of 632 patients aged 15-79 years. At baseline, 58% of the patients had severe disease; the mean body surface area affected was 46%. More than 80% of patients had eczema affecting the face and/or neck region.

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