Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Pfizer Zoloft Ad Cited By FDA For Omitting Suicide Risk

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's ad review division objects to an October print ad for the antidepressant that failed to mention the risk of suicidality and clinical worsening. The ad's brief summary referenced information from outdated labeling, the agency says.

You may also be interested in...



Pfizer's Parecoxib Ad Cited By U.K. For Using Out-Of-Date Labeling

A journal ad for parecoxib, marketed as Dynastat in the U.K., did not mention two warnings recently added to the COX-2 inhibitor for use in congestive heart failure and coronary artery bypass graft patients. The Medicines & Healthcare Products Regulatory Agency is requesting a corrective statement. The parecoxib NDA is pending at FDA.

Pfizer's Parecoxib Ad Cited By U.K. For Using Out-Of-Date Labeling

A journal ad for parecoxib, marketed as Dynastat in the U.K., did not mention two warnings recently added to the COX-2 inhibitor for use in congestive heart failure and coronary artery bypass graft patients. The Medicines & Healthcare Products Regulatory Agency is requesting a corrective statement. The parecoxib NDA is pending at FDA.

Pfizer Pulling Back “Traditional” DTC Ads, CEO McKinnell Says

The company is moving away from campaigns promoting brand awareness in favor of ads focusing on disease awareness and patient education, the Pfizer exec says. There is a “recognition” in the pharmaceutical industry that direct-to-consumer advertising needs to be reformed, McKinnell notes.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062342

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

Cancel