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Web site reference to full labeling does not create balance; FDA challenges Abelcet home page.

Executive Summary

THE LIPOSOME COMPANY ABELCET HOME PAGE LINK TO LABELING NOT "SUFFICIENT" to provide fair balance, FDA's Division of Drug Marketing, Advertising & Communications told the company in a Dec. 11 letter. "DDMAC does not consider the mere inclusion of a reference to a product's full prescribing information as being sufficient to balance any claims being made," the letter states. The Abelcet home page (www.lipo.com) includes an Internet link to full prescribing information. Abelcet is amphatericin B lipid complex indicated against invasive fungal infections.
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PS029372

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