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Antifungal drug products

This article was originally published in The Tan Sheet

Executive Summary

FDA amends final monograph for athlete's foot (tinea pedis) products to add the word "most" to product labeling. New labeling will read, "For effective treatment of most athlete's foot with daily use," or contain a similar statement, an Aug. 29 Federal Register notice says. Companies selling antifungal treatments with sales greater than $25,000 per year must comply by May 16, 2002, all other companies must comply by May 16, 2003; the proposed amendment to the 1993 monograph was issued in July 1999. CHPA commented in October that the change was unsupported by scientific evidence and would not "meet an important consumer need" (1"The Tan Sheet" Nov. 1, 1999, p. 6)

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