FDA calls on companies to end marketing of unapproved suppositories

Share this article:
The FDA asked five drugmakers to end the manufacturing and marketing of suppository drug products containing trimethobenzamide hydrochloride, due to lack of evidence of effectiveness. The products, used to treat nausea and vomiting in adults and children, have been marketed under various names including Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz. The FDA is asking five manufacturers and six distributors of the unapproved suppositories to stop making and distributing them. The agency did not immediately identify the drug companies and distributors. Companies making or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, the FDA said. A small amount of these products will still be available in pharmacies until supplies are exhausted. After May 9, any company wishing to market a product containing trimethobenzamide in suppository form must obtain an approved New Drug Application prior to marketing, the agency said. If the companies and distributors do not comply, the government can seize the products and force the companies to stop making the drugs through a court order. The action is part of an ongoing FDA effort to pursue prescription drugs that do not have agency approval. Many of those unapproved drugs were on the market prior to a 1962 law requiring the agency to evaluate a drug’s safety and effectiveness before allowing it on the market. Earlier laws focused mainly on drug safety.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...