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

Remodulin Journal Ad, Booklet Prompt FDA Warning Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

United Therapeutics' promotional materials make misleading comparisons between Remodulin and GlaxoSmithKline's Flolan, FDA's ad review division says. The company says it discontinued the ads and requested doctors stop using the "Frequently Asked Questions" booklet in July 2004.

You may also be interested in...



United Therapeutics’ Remodulin Approved For Transition From GSK’s Flolan

The expanded indication completes Remodulin’s accelerated approval requirements.

United Therapeutics’ Remodulin Approved For Transition From GSK’s Flolan

The expanded indication completes Remodulin’s accelerated approval requirements.

Schering, GSK Reviewing Levitra Promotions After FDA Cites 15-Second TV Ad

Commercial for Levitra does not qualify as "reminder ad" because it includes effectiveness claims, agency says in an ad division letter. Acting Commissioner Crawford has expressed a desire to crack down on DTC ads in the erectile dysfunction category. Levitra is one of four products cited by the agency in letters posted over a two-day period.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062001

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