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FDA Objects to Certain Promotional Materials for Kogenate FS®

The U.S. Food and Drug Administration (FDA) sent a letter to Bayer HealthCare informing the pharmaceutical company that several of the promotional materials for its recombinant factor VIII product, Kogenate FS®, are misleading. The letter, sent from the FDA’s Office of Compliance and Biologics Quality (OCBQ) on January 23, 2006, focused on materials that were sent to patients and doctors announcing a free trial program for Kogenate FS®.

OCBQ regulators specifically stated that the promotion neglected to include enough information about the risks associated with the product or sufficient directions for its use. OCBQ requested that Bayer immediately cease using the “misbranded” materials and to comply with applicable sections of the Federal Food, Drug and Cosmetic Act (21 U.S.C.) in future promotions.

In response to the FDA’s objection, Bayer issued a separate communication to the recipients of the trial program. This letter included the necessary information on risks and directions for use.

Source: Reuters, January 25, 2006


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