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FDA denies acne amendment

This article was originally published in The Tan Sheet

Executive Summary

D'Arcy Skincare's petition to amend the OTC topical acne drug products monograph and affirm the combination of sulfur 10% and salicylic acid 2% as generally recognized safe and effective was rejected by the agency. FDA says it is "unaware of any clinical studies demonstrating that both sulfur and salicylic acid contribute to the overall effectiveness of the combination" and that D'Arcy did not submit any data on effectiveness in its petition. D'Arcy had maintained there were no reported adverse events for its Drying Lotion acne treatment, which contains the combination, following more than 20 years of marketing; the firm also submitted a repeat insult patch test for support of safety and consumer testimonials to prove efficacy...

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