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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.


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