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Hoechst Amaryl slide presentations include violative superiority claims, FDA tells company.

Executive Summary

HOECHST AMARYL SUPERIORITY CLAIMS TO OTHER SULFONYLUREAS DRAW FDA OBJECTION in a Dec. 6 notice of violation letter from the Division of Drug Marketing, Advertising & Communications. Slide and lecture kits produced by HMR for Amaryl (glimepiride) for its April launch include superiority claims that are "misleading because the data from the clinical trials were not adequate to support claims of differences in either safety or efficacy between Amaryl and other sulfonylureas," DDMAC maintained. The letter refers to four previous DDMAC communications on the subject to Hoechst Marion Roussel.
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