Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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...

You may also be interested in...

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)...

Akorn Defaults On Loan Agreement After Sale Bid Falls Flat

Facing soaring legal costs stemming from its failed merger with Fresenius Kabi and burdened by substantial debt, Akorn elected to put itself up for sale earlier this year in order to help repay lenders. But the company has now defaulted on an agreement with its creditors after no bidder stepped up to the plate.

Pipeline Watch: Vericiguat, Evinacumab Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts