Scrip 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

US promotion for Wyeth's Benefix is misleading, FDA says

This article was originally published in Scrip

Executive Summary

A promotional flashcard for Wyeth's recombinant Factor IX product Benefix is misleading because it presents unsubstantiated superiority safety claims, the US FDAhas said. The flashcard suggests the recombinant nature of Benefix makes it safer than CSL Behring's plasma-derived Factor IV product Mononine for treating haemophilia B. "The overall presentation suggests that there is no viral risk associated with Benefix and that plasma-derived products such as Mononine are virally unsafe," the FDA said. Wyeth said it started using the flashcard in November but discontinued use last month before receipt of the FDA's violation letter. The company has responded to the agency and is making corrections to the promotion for future use.

Topics

Related Companies

UsernamePublicRestriction

Register

SC002179

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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