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3M Aldara submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

3M submits sNDA for use of its topical immune response modifier Aldara (imiquimod cream, 5%) for superficial basal cell carcinoma. The submission is based on two six-week, double-blind, placebo-controlled studies in 724 patients. The studies found dosing five times a week to be the optimal regimen, with a histological clearance rate of 82% vs. 3% for placebo. Aldara could also be cleared for another indication in 2004; 3M submitted an sNDA May 5 for actinic keratosis (1Pharmaceutical Approvals Monthly June 1, 2003, p. 15)...

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