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Bayer Marketing Two Unapproved Aspirin Products: FDA
Date:10/28/2008

rch, said in the news release. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health-care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

FDA officials said they weren't aware of any significant adverse events associated with Bayer Women's or Bayer Heart Advantage.

If companies fail to resolve violations cited in FDA warning letters, they face enforcement action such as injunctions and/or seizure of illegal products.

More information

The FDA has more about its drug approval process.



-- Robert Preidt



SOURCE: U.S. Food and Drug Administration, news release, Oct. 28, 2008


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