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FDA withdraws monograph bid for diarrhea drug

This article was originally published in The Tan Sheet

Executive Summary

FDA withdraws its 2004 notice of eligibility and request for information to aid its consideration of adding Saccharomyces boulardii to the antidiarrheal OTC drug product monograph. FDA determined the yeast is best regulated as a biological product, the agency said in an Oct. 27 notice in the Federal Register (1"The Tan Sheet" Aug. 23, 2004, In Brief)

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