FDA Takes Action to Stop Unapproved Marketing of Guaifenesin Drugs
The U.S. Food and Drug Administration plans to stop companies that sell unapproved drug products in time-release dosage form that contain guaifenesin. Guaifenesin is a substance usually used to relieve cough and cold symptoms by causing removal of mucus from the lungs. About 20 companies currently make timed-release products that contain guaifensin that have not been reviewed by the FDA.
Action Taken to Stop Marketing of Unapproved Timed-Release Guifenesin Drug Products
Steven K. Glason, the director of the FDA's Center for Drug Evaluation and Research, says that "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. 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."
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