FDA Takes Action to Stop Marketing of Unapproved Time-Released Drug

The U.S. Food and Drug Administration (FDA) recently announced it will take action against companies that market unapproved, time-release drugs--often described as extended-release, long-acting, or sustained-release--that contain guaifenesin, a substance commonly used to relieve cough and cold symptoms to remove mucous from the lungs. The FDA estimates there are 20 such firms selling unapproved products.

"Today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "This benefits consumers because drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured."

This action does not affect products containing guaifenesin in immediate release form. FDA approval is necessary to ensure that the product releases its active ingredients safely and effectively, sustaining the intended effect over the entire time in which the product is intended to work.

Presently, only Adams Respiratory Therapeutics has obtained such FDA approval under the trade names of Mucinex and Humibid.

Companies marketing unapproved products containing guaifenesin in timed-release form are advised to stop manufacturing them within 90 days and cease shipping them in interstate commerce within 180 days. After these dates, companies wishing to market products containing guaifenesin in timed-release form must obtain approval or face regulatory action.

For more information, visit FDA's Unapproved Drugs Web site at www.fda.gov/cder/drug/unapproved_drugs/default.htm.

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