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FDA Announcement Regarding Suppository Products

As part of the FDA's ongoing initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced this week that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride.

These products are used to treat nausea and vomiting in adults and children. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. These products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.

There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories. Several oral capsules and injectable products containing trimethobenzamide have been approved by the FDA and are not affected by this week's action.