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Clariant TEA extension request

This article was originally published in The Tan 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 & Heckman says in a letter to FDA filed April 16 on behalf of Clariant. The agency issued a call for safety and efficacy data on piroctone olamine as a single active dandruff control ingredient in February to determine its eligibility for monograph status. Review follows submission of a time and extent application by Clariant...

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Piroctone olamine TEA extension

FDA grants manufacturer Clariant's request for a 90-day extension of public comment period for anti-dandruff ingredient safety and efficacy review to August 16. The agency "considers an extension of time for submission of data, information and general comments concerning the safety and effectiveness of piroctone olamine to be in the public interest," according to a May 19 Federal Register 1notice. Clariant had requested more time to assemble a "more comprehensive" submission (2"The Tan Sheet" May 10, 2004, In Brief)...

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