FDA Chews Out Angiomax Maker Over Promo Materials

Law360, New York (April 27, 2012, 4:27 PM EDT) -- The U.S. Food and Drug Administration has fired off a violation notice to The Medicines Co. over allegedly misleading promotional materials for blood thinner Angiomax, according to a notice posted this week on the agency's website.

At issue is a booth panel the FDA reviewed and found to be “false or misleading because it omits important risk information associated with the drug and presents unsubstantiated superiority claims.”

Certain warnings about use of the anticoagulant were completely omitted, including one cautioning that “Angiomax should be used with...
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