FDA Tells Baxter To Tone Down Tisseel Marketing

Law360, New York (May 5, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has taken Baxter International Inc. to task over alleged overstatements contained in the company’s marketing material for Tisseel, a surgical sealant.

In a warning letter sent April 14 and released Tuesday, the FDA accused the company of making claims about Tisseel’s efficacy that are not supported by cited studies, and adopting a Tisseel tagline that suggests its use for procedures for which it has not been approved.

“The presentation, brochure and sell sheet are false or misleading because these materials,...
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