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Aventis Amaryl

Executive Summary

FDA objects to claims made by Aventis sales aid and website that the company's diabetes drug "Amaryl is tailored to demonstrate an insulin-sensitizing effect," and "Tailor glucose control with Amaryl means...improving insulin sensitivity and targeting insulin resistance." The claims are misleading because "they strongly suggest that Amaryl works primarily by improving insulin sensitivity and targeting insulin resistance when such is not the case," FDA told the company in a March 8 letter. FDA also cited a sales aid for claiming that Amaryl causes a 3.7% decrease in HbA1c based on a 30-patient study. The agency notes that "the average net reduction in HbA1c with Amaryl in 720 patients treated with once daily was 2% compared with placebo-treated patients." FDA asked Aventis to discontinue promotions making such claims
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PS037497

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