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Unapproved suppositories

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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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