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OTC review

This article was originally published in The Tan Sheet

Executive Summary

FDA issues call for data on antidiarrheal ingredient Saccharomyces boulardii 250 mg in capsule form taken one to two times daily, according to a notice slated for publication in the Federal Register Aug. 23. The agency "has reviewed a time and extent application for this condition and determined that it is eligible for consideration in its OTC drug monograph system." The notice adds that either an official or proposed U.S. Pharmacopoeia-National Formulary monograph must be submitted as part of the review because one was not included as part of the TEA...
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