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

UsernamePublicRestriction
UsernamePublicRestriction

Viramune Print Ad Cited By FDA For Risk Minimization

This article was originally published in The Pink Sheet Daily

Executive Summary

Boxed text providing risk information for the HIV therapy uses print that is too small and omits necessary statements, FDA's ad division says. Boehringer Ingelheim must present FDA with a plan to discontinue using the ad by Oct. 6.

You may also be interested in...



FDA Warning Letter Snuffs Out Boehringer's Atrovent/Combivent Ads

The ad, which features birthday candles being blown out, makes unsubstantiated effectiveness claims, an FDA warning letter states. Boehringer Ingelheim said the ad is no longer in use; the company plans to distribute corrective information.

FDA Warning Letter Snuffs Out Boehringer's Atrovent/Combivent Ads

The ad, which features birthday candles being blown out, makes unsubstantiated effectiveness claims, an FDA warning letter states. Boehringer Ingelheim said the ad is no longer in use; the company plans to distribute corrective information.

Viramune Labeling Revision Warns Of Hepatic Failure In High-Risk Population

High-risk women taking the HIV agent should be closely monitored for hepatotoxicity during the first 18 weeks of treatment, a "Dear Doctor" letter states.

Topics

UsernamePublicRestriction

Register

PS051363

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