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Unapproved suppositories

Executive Summary

Companies must cease manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride, used to treat nausea and vomiting, because such products "lack substantial evidence of effectiveness," FDA says in a Federal Register notice. Suppositories containing trimethobenzamide hydrochloride have included Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz, the agency notes. Firms must stop shipping them in interstate commerce by May 9, and obtain a new drug application to resume marketing, FDA adds in an April 6 press release. The notice also announces the withdrawal of King's NDA for Tigan suppositories...

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