FDA to Stop Sales of Unapproved Timed-Release Cold Medications

(HealthDay News) -- The U.S. Food and Drug Administration said Friday that it plans to stop companies from marketing unapproved products that contain the cold treatment guaifenesin in unapproved timed-release form.

Guaifenesin is commonly used in medicines to treat cough and cold symptoms by stimulating removal of mucus from the lungs.

"Today the FDA is issuing a notice that guaifenesin in timed-release form cannot be marketed without approved application," Deborah M. Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research, said during an afternoon teleconference.

The ban does not include products containing guaifenesin that are in immediate-release form, she said.

Some 20 companies make timed-release products containing guaifenesin, and approximately 65 firms distribute these products, Autor said. "These medications have bypassed FDA's approval process," she said. "The FDA has not determined that they are safe and effective as formulated and manufactured."

The FDA requires that timed-released drugs be approved. The agency wants to be sure that the products' active ingredients are released safely and effectively, and maintain their effect over the time the product is intended to work, Autor said.

According to Autor, the ban includes the top-selling drugs Guaifenex, Crantex and Amibid. These and other guaifenesin timed-released drugs are available by prescription only.
Autor noted that so far, only Adams Respiratory Therapeutics has gotten FDA approval for timed-release products containing guaifenesin. These products are sold under the names Mucinex and Humibid.

The FDA expects companies selling unapproved products containing guaifenesin to stop manufacturing them within 90 days. In addition, they must stop shipping them in interstate commerce within 180 days.

"Manufacturers must stop making timed-released drug products containing guaifenesin no later than August 27, 2007," Autor said. "Firms must stop shipping the products no later than November 25, 2007."

After these dates, companies that want to sell products containing guaifenesin in timed-release form must get FDA approval or face regulatory action.

More information
For more information on unapproved drugs, visit the U.S. Food and Drug Administration.