FDA Cites Companies for Selling Unapproved Suppositories

The FDA has ordered companies to stop manufacturing unapproved suppository products containing trimethobenzamide hydrochloride because the drugs lack proof of efficacy.

The move was the latest in the agency's crackdown on unapproved drugs, FDA Director for the Division of New Drugs and Labeling Compliance Michael Levy said.

The prescription suppositories, used to treat nausea and vomiting, are sold under the names Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz, according to the agency. Approximately five manufacturers and six distributors sell the drugs, which are a "relatively small" part of the treatment market, Levy said.

Several effective alternatives, including FDA-approved oral capsules and injectable products containing trimethobenzamide, are available to treat nausea and vomiting, the agency said. Companies must stop shipping the unapproved drugs by May 9, the FDA said. If a company wishes to continue marketing the suppositories, it must submit a new drug application (NDA), the agency added.

In 1979, the FDA made an initial determination to hold hearings on a proposed withdrawal of all NDAs for the suppositories as part of its Drug Efficacy Study Implementation program, the agency said. Beecham requested a hearing on the proposed withdrawal of its NDA for Tigan suppositories. In 1999, King Pharmaceuticals purchased the NDA from Beecham, and in 2005 King requested that the FDA withdraw the NDA.

After King withdrew the NDA and its request for a hearing, the FDA determined it could withdraw all NDAs for the suppositories, the agency said.