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FDA requests Aquafresh material time/material extent marketing data.

This article was originally published in The Rose Sheet

Executive Summary

FDA REQUESTS AQUAFRESH MATERIAL EXTENT/MATERIAL TIME MARKETING DATA to support the inclusion of the toothpastes' active ingredient -- calcium carbonate -- in the OTC drug review process, states a May 4 letter from the agency to SmithKline Beecham Consumer Healthcare. FDA's letter explains that in order to be eligible for monograph status "an active ingredient must have been marketed in a product with the relevant indication...to a material extent and for a material time."
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