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Comments on Topical Antifungal Drugs TFM

Executive Summary

In recent comments on the Tentative Final Monograph for OTC topical antifungals, the Nonprescription Drug Manufacturers Association asked that FDA state in the preamble to the Final Monograph "that new combinations will be considered if new data are submitted." NDMA and Schering-Plough in separate comments requested that FDA not classify "claims regarding speed of symptomatic relief and onset of fungicidal activity provided by antifungals" as Category II, but rather consider them outside the scope of the monograph. NDMA and Schering also proposed that FDA shorten the directions for use and warnings in labeling of such products.
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