FDA To Review Piroctone Olamine For OTC Dandruff Monograph Status
This article was originally published in The Rose Sheet
Executive Summary
FDA is seeking safety and efficacy data on piroctone olamine for use as a single active ingredient in dandruff control products, the agency announced in a Federal Register 1notice Feb. 18
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Octopirox Data Supports Inclusion In OTC Anti-Dandruff Rule – Clariant
The safety and efficacy of dandruff control ingredient piroctone olamine in .05%-.5% and .1%-1% concentrations in leave-on and rinse-off products, respectively, is established by animal and human data, warranting the ingredient's inclusion in the OTC anti-dandruff monograph, according to Clariant
Octopirox Data Supports Inclusion In OTC Anti-Dandruff Rule – Clariant
The safety and efficacy of dandruff control ingredient piroctone olamine in .05%-.5% and .1%-1% concentrations in leave-on and rinse-off products, respectively, is established by animal and human data, warranting the ingredient's inclusion in the OTC anti-dandruff monograph, according to Clariant
Clariant TEA extension request
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...