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Executive Summary

OTC ANTICARIES ACTIVE INGREDIENT COMBINATION WITH ORAL DISCOMFORT AGENTS and other active ingredients should be included in the OTC anticaries product monograph, Block Drug suggested in recent comments to FDA. Block recommended that the proposed anticaries rule allow any anticaries active ingredient to "be combined with one or more active ingredients" approved via the monograph process as "oral mucosal injury agents, drugs for the relief of oral discomfort, or oral health care drug ingredients." Block asserted that the three cited types of drug products should be included as possible combination ingredients in the anticaries monograph because they "would be of value to 'a significant proportion of the target population' as 'rational concurrent therapy' when used in combination with anticaries drug products." Block noted that "the mfr. of each permitted combination drug product would be responsible for demonstrating that such combination is both safe the effective for each indication." Block also commented on FDA's intention to publish a second section to the anticaries TFM which will describe how in vitro testing of anticaries agents should be conducted. The firm maintained "that this data should more aptly be placed on file" for review "as a 'guideline' document for mfrs. to consult vis-a-vis appropriate in vitro methods for substantiating efficacy of anticaries drug products."

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