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


Pfizer’s Effort To Remove Chantix Boxed Warning May Backfire

This article was originally published in The Pink Sheet Daily

Executive Summary

Most FDA advisory committee members vote to wait until clinical trial results are submitted, but some also say warning should be include additional adverse events.

You may also be interested in...

FDA Makes Rare Call, Removes Boxed Warning From Chantix, Zyban Labels

Pfizer, GSK score as neuropsychiatric symptom risks now only appear in Warnings and Precautions section following EAGLES trial results.

Removing Pfizer's Chantix Boxed Warning A One-Off, Committee Says

Advisory committee says data supports dialing back safety label for the smoking cessation product, but shouldn’t be precedent setting.

Pfizer's Chantix Warning May Remain As FDA Raises Trial Concerns

FDA will present concerns on data collection and study conduct during advisory committee meeting on removing smoking cessation drug's boxed warning.

Related Content


Related Companies




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