FDA Calls for Data on OTC Anti-diarrheal Ingredient
08/23/2004
Federal Register Notice: FDA is calling for data on safety and effectiveness information on the following condition as part of the agency’s ongoing review of OTC drug products: Saccharomyces boulardii (S. boulardii), 250 mg (4.5 x 10\9\ lyophilized, viable yeast cells) taken one to two times daily with a maximum daily dose of 500 mg (9.0 x 10\9\ yeast cells), in capsule form as an anti-diarrheal ingredient. FDA has reviewed a time and extent application for this condition and determined that it is eligible for consideration in its OTC drug monograph system. To view this notice, click here.
