Law360, New York (May 05, 2009, 12:00 AM ET) -- 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,...
FDA Tells Baxter To Tone Down Tisseel Marketing
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