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FDA Warns Bayer Over Aspirin-Supplement Combos

Law360 (October 28, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has issued two warning letters to Bayer AG division Bayer HealthCare, which the agency said has illegally marketed two over-the-counter aspirin products that have not yet received the FDA's stamp of approval.

The FDA's letters, which are addressed to Bayer president Gary S. Balkema and dated Oct. 27, raise concerns about Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium, which the agency said require an approved new drug application in order to be legally marketed....
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