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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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