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Antidiarrheal drug products

This article was originally published in The Tan Sheet

Executive Summary

FDA informs Merrick Medicine, marketer of Percy Medicine antidiarrheal product that "no antacid- antidiarrheal combinations have been approved by the agency as safe and effective for OTC use" in a July 12 letter. Merrick Medicine claimed that its product "utilizes an antacid vehicle of other drugs" to deliver the product's main ingredient, bismuth subnitrate. FDA further states that "if Percy Medicine is a combination antacid-antidiarrheal," clinical data must be submitted to the agency in either an NDA or a citizen petition amending the antacid monograph to support safety/efficacy. The status of bismuth subnitrate will be addressed, the agency notes, in the final monograph for OTC antidiarrheal products

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