FDAnews Marketing and Sales Bulletin

The FDA will take enforcement action against companies marketing approximately 200 unapproved cough suppressants containing the narcotic hydrocodone, the agency announced.

Many of the cough suppressants contain improper labeling lacking adequate warnings, according to the FDA. Some of the unapproved products are marketed for children although the FDA has not approved a cough suppressant containing hydrocodone as safe and effective for children under 6, Center for Drug Evaluation and Research (CDER) Director Steven Galson said.

Some of the unapproved products have names similar to approved drug products, causing confusion for consumers, CDER Office of Compliance Director Deborah Autor said. Improper labeling and unapproved formulations of the product can lead to improper dosing, she added.

The step is part of the agency’s initiative to assure all drugs marketed in the U.S. are FDA-approved, Autor said. It is the agency’s sixth announced action since June 2006, when the agency released a compliance policy guide outlining new enforcement policies.

Manufacturers marketing unapproved hydrocodone products labeled for use in children younger than 6 years must stop making and distributing the products on or before Oct. 31, the FDA said. Manufacturers marketing all other unapproved hydrocodone products must stop manufacturing them on or before Dec. 31 and stop distributing them on or before March 31, 2008.