FDA decided that companies must stop manufacturing and distributing unapproved suppository drugs containing trimethobenzamide hydrochloride as they lack evidence of effectiveness. These products are used to treat nausea and vomiting.
“FDA is continuing its work to remove unapproved drugs from the market,” remarks Steven Galson, M.D., director of FDA’s Center for Drug Evaluation and Research. “FDA is committed to ensuring that the medicines Americans rely on when they are sick are proven to be effective and safe.”
In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require that drugs be shown to be effective, as well as safe. Under the Drug Efficacy Study Implementation (DESI), FDA investigated Roche-held NDAs for Tigan solution for injection, Tigan capsules, and Tigan suppositories as well as Beecham Laboratories’ NDA for Tigan suppositories.
Because DESI findings apply to any unapproved products that are identical, related, or similar to DESI-reviewed drugs, today’s notice makes the marketing of any unapproved trimethobenzamide hydrochloride suppository products unlawful.
“Prescription drugs that have not gone through the FDA approval process are of unproven safety and effectiveness,” said director of CDER’s Office of Compliance, Deborah M. Autor. “Today’s action helps ensure that healthcare providers prescribe and consumers take only medicines shown to be effective.”
Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007. Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved NDA prior to marketing.