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Topical antifungals monograph

This article was originally published in The Tan Sheet

Executive Summary

FDA issues final rule in Feb. 8 Federal Register recognizing clotrimazole 1% as safe and effective treatment for athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) under topical antifungal drug products final monograph. Active ingredient in Schering-Plough's Lotrimin AF has been marketed OTC under an NDA since 1989. Agency estimates reg could result in one-time relabeling costs of $50,000-$75,000. FDA originally announced its intention to amend the monograph in May (1"The Tan Sheet" May 28, 2001, p. 3)...

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