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Clotrimazole 1% "more detailed" data needed to consider monograph status, FDA says.

This article was originally published in The Tan Sheet

Executive Summary

CLOTRIMAZOLE 1% "MORE DETAILED" SAFETY, EFFECTIVENESS DATA NEEDED for FDA consideration of the ingredient for inclusion in the OTC monograph for antifungal products, the agency tells Schering-Plough in a Sept. 18 letter. In a preliminary response to Schering-Plough's Nov. 27, 1996 citizen petition requesting monograph status for the ingredient, FDA states that "referral to an IND...and NDAs...is not acceptable because the agency cannot place the data in those applications in the public record under the petition docket" without the sponsor's permission.
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