The agency is requiring companies to stop making and distributing unapproved suppositories containing trimethobenzamide hydrochloride due to lack of evidence of effectiveness. The products are marketed under such names as Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. The products can’t be shipped after May 9.

This is part of a recent FDA effort to restrict the large number of unapproved drugs that are widely marketed, but contineu to fly under just about everyone’s radar screens, from doctors to pharmacists.

Last month, for instance, the FDA told 20 companies to stop selling unapproved drugs containing ergotamine tartrate, which were used to treat vascular headaches, including migraines. In December, the FDA told several companies to stop selling unapproved drugs containing quinine, which is used to treat malaria, but was marketed off-label for treating leg cramps.

This is a good move by the agency, given that there seems to be such little awareness of the extent to which unapproved drugs are circulating. What remains to be seen is whether the FDA brass is willing to apply and maintain as much scrutiny on brand-name drugmakers that pay those big PDUFA fees.

FDA statement on unnaproved suppositories;
FDA actions and statements on unapproved drugs.

[tags]FDA, Suppositories, Tigan[/tags]