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FDA Takes Aim At Unapproved Cough Drugs

Law360 (May 25, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration said Friday it will take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin, a substance commonly used in cough and cold medicines.

Approximately 20 companies currently manufacture timed-release products containing guaifenesin that have not undergone FDA review, and as a result are considered by the agency to be unapproved drugs, the FDA said.

“Today’s action is another example of our commitment to ensure all drugs marketed in the United States that require FDA...
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