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


Tazoral Risk Management Plan Resubmission May Affect Approval Timeline

This article was originally published in The Pink Sheet Daily

Executive Summary

Allergan will resubmit a revised risk management program for Tazoral as a result of the negative review by FDA’s advisory committees. The resubmission could extend the user fee date of the oral retinoid, Allergan says.

You may also be interested in...

Accutane Risk Management Program Changes Held Up By Celgene Patents

Four patents relating to the STEPS risk management program for Thalomid are an “obstacle” to implementing an augmented isotretinoin program, FDA says. The agency’s Office of Chief Counsel is reviewing the issue.

NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter

DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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