FDA Warns Sanofi Over 'Misleading' Uroxatral Ads

Law360, New York (October 27, 2009, 6:28 PM EDT) -- The U.S. Food and Drug Administration has warned drugmaker Sanofi-Aventis that a promotional advertisement for its prostate treatment Uroxatral misbrands the drug, in violation of the Federal Food, Drug and Cosmetic Act.

The FDA's Division of Drug Marketing, Advertising and Communications sent the warning letter to Sanofi on Friday after reviewing a voucher tent card for Uroxatral extended-release tablets that the DDMAC found to be “misleading” because “it presents efficiency claims for Uroxatral but fails to communicate its indication or information about the risks associates with...
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