WEDNESDAY, May 30 (HealthDay News) -- The U.S. Food and Drug Administration plans to stop the marketing and sale of unapproved drugs containing timed-release guaifenesin, which is often found in cough and cold suppressants. The move affects products from about 20 companies but does not include immediate-release guafenesin-containing drugs.
Only one company, Adams Respiratory Therapeutics, has won FDA approval for drugs containing 600 and 1,200 milligrams of timed-release guaifenesin, including Mucinex and Humibid.
Firms making unapproved timed-release guaifenesin-containing drugs must stop making them within 90 days and halt interstate shipments in six months.
"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," Steve Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.
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