FDA Tells Cedax Maker To Fix Deceptive Marketing

Law360, New York (November 25, 2008, 12:00 AM EST) -- The marketing for Shionogi & Co. Ltd.’s antibiotic Cedax misleads the public by downplaying the drug’s risks and overstretching efficacy claims, the U.S. Food and Drug Administration said in a warning letter to the company on Nov. 14.

The FDA sent a letter ordering Shionogi USA Inc. CEO Sapan A. Shah to update the company's promotional materials to provide more accurate drug claims.

“These violations are concerning from a public health perspective because they suggest that the product is both safer and effective in a broader...
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