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FDA Clamps Down on Marketing of Unapproved Hydrocodone Products

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The FDA plans to take enforcement action against companies that continue to market drug products containing the popular but addictive hydrocodone. The move is intended to target those drugs marketed especially to children to suppress coughs. “Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs,” said Steven K. Galson, M.D., M.P.H., director of the FDA’s Center for Drug Evaluation and Research (CDER). “A case in point – no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.”