FDA Announces Withdrawal Of Unapproved Suppository Drugs For Nausea/Vomiting
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency also is revoking NDA approval of King’s Tigan trimethobenzamide suppositories.
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Manufacturers of unapproved suppository drug products used to treat nausea and vomiting that contain trimethobenzamide must cease marketing the products because they "lack substantial evidence of effectiveness," FDA says in a Federal Register notice slated to be published April 9. "Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved new drug application prior to marketing," the agency adds in an April 6 press release announcing the action. Suppositories containing trimethobenzamide hydrochloride have been marketed under names such as Tebamide , T-Gen , Trimazide and Trimethobenz , FDA notes. There are five manufacturers and six distributors of those products in the U.S., CDER Division of New Drugs and Labeling Compliance Director Michael Levy said during an April 6 conference call. Known distributors include Shire U.S. Manufacturing and BioPharm, according to the agency. The action is the fourth removal of a product by FDA following the introduction of its "Marketed Unapproved Drugs - Compliance Policy Guide," which outlines the agency's plans for taking enforcement action against unapproved drugs on the market (1 (Also see "FDA Kicks Off Unapproved Drug Crack-Down With Carbinoxamine Enforcement" - Pink Sheet, 8 Jun, 2006.)). The other three drugs taken off the market in the past year contain carbinoxamine, quinine and ergotamine. The agency's decision to remove unapproved ergotamine products came in early March (2 (Also see "Ergotamine Drugs Are Latest Target In FDA Crackdown On Unapproved Medications" - Pink Sheet, 1 Mar, 2007.)). "We have issued many warning letters to manufacturers that are making unapproved drugs, as well as violating other provisions of the [Federal Food, Drug and Cosmetic] Act. And, we have pursued multiple court cases against unapproved drug manufacturers," FDA told "The Pink Sheet" DAILY. The Federal Register notice also announces that FDA is withdrawing its approval of King Pharmaceuticals' NDA for Tigan (trimethobenzamide hydrochloride) suppositories. The company assumed the NDAs for the Tigan franchise, which includes suppository, injectable and capsule products, from Roberts Pharmaceutical Corp. in 1999; after deciding to forego additional studies of the suppository drug to support approval, the firm agreed to withdraw the NDA in September 2005. Issues with the Tigan capsule and injection versions were resolved in 2001 and 2002, FDA says. The announcement that FDA will require NDAs for the suppositories comes more than 30 years after the agency first released a 1971 notice on trimethobenzamide as part of the Drug Efficacy Safety Implementation program. In two separate 1979 notices, FDA proposed to withdraw all approvals of NDAs for trimethobenzamide injection and capsule products, as well as suppositories. In 2002, the agency announced that injection and capsule products must obtain approval of an NDA or ANDA. - Brooke McManus ([email protected]) |