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Clariant TEA extension request

This article was originally published in The Rose Sheet

Executive Summary

Piroctone olamine manufacturer Clariant seeks 90-day extension to "assemble a comprehensive submission" to FDA on the safety and efficacy of the anti-dandruff ingredient. Firm requests original deadline of May 18 be pushed back to Aug. 16, Washington, D.C. law firm Keller and Heckman says in letter to FDA filed April 16 on behalf of Clariant. Agency issued a call for safety and efficacy data on piroctone olamine as a single active dandruff control ingredient in February to determine if it is eligible for monograph status (1"The Rose Sheet" Feb. 23, 2004, p. 10). Review follows submission of a time and extent application by Clariant...

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