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FDA Sends Bayer Warning Letters

October 28, 2008

The U.S. Food and Drug Administration said it has sent warning letters to Bayer HealthCare concerning over-the-counter sales of two of its aspirin products.

The FDA said the over-the-counter sale of Bayer Women’s Low Dose Aspirin plus Calcium and Bayer Aspirin with Heart Advantage is unlawful.

“The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed,” the FDA said in a statement. “In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women’s is also labeled for use in fighting osteoporosis. Neither product has been approved by the FDA for such uses.”

Officials said both products require a healthcare professional’s diagnosis and supervision, and therefore cannot be labeled for use by consumers and sold over-the-counter.

“The FDA considers these products new drugs and thus they must undergo the FDA’s drug approval process,” said Mike Chappell, acting associate commissioner for regulatory affairs. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”




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