We use cookies on this site to enable your digital experience. By continuing to use this site, you are agreeing to our cookie policy. close

FDA Tells Baxter To Tone Down Tisseel Marketing

Law360 (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,...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.