FDA to Take Action Against Companies Marketing Unapproved Guaifenesin Products

May 31, 2007
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Rockville, MD (May 25)—The US Food and Drug Administration (www.fda.gov) issued a statement announcing its intention to take action against companies that market unapproved timed-release drug products that contain guaifenesin. Guaifenesin stimulates the removal of mucous from the lungs and is used in medications to relieve cough and cold symptoms.

According to FDA, approximately 20 firms manufacture timed-release products containing guaifenesin that have not undergone FDA review. Drugs that have not been reviewed by FDA are considered unapproved and can pose a threat to consumers. “Drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured,” says Steven K. Galson, the director of FDA’s Center for Drug Evaluation and Research in the statement issued by FDA.

Only one company, Adams Respiratory Therapeutics (Chester, NJ, www.adamsrt.com) currently has FDA approval for timed-release products containing guaifenesin. The products are sold under the trade names of “Mucinex” and “Humibid.” Adams is applauding FDA’s move against those marketing unapproved products.

FDA ordered companies marketing the unapproved products to stop manufacturing them within 90 days and to cease shipping them within 180 days. Those companies that wish to continue marketing the products must obtain FDA approval.  The full text of FDA’s statement can be found here.