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Published on 1 October 2007

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FDA targets firms over unapproved opioid

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The FDA has launched a crackdown against companies in the USA marketing unapproved drugs containing the painkiller and cough suppressant hydrocodone.

The move is part of a broader effort to remove from sale an estimated 200 unlicensed prescription cough medicines made with the narcotic.

Drug companies now have until 31 October to stop making and selling any unapproved medicines labelled for use by children younger than six that contain the medication.

Manufacturers of any other unapproved hydrocodone medicines must stop making them by 31 December, and stop shipping them by 31 March next year.

The order does not apply to seven cough suppressants made with the opioid that do have FDA approval.

And pain-relief drugs such as Vicodin, which combines hydrocodone and acetaminophen, are also exempt.

Dr Steven Galson, director of the FDA’s Center for Drug Evaluation and Research (CDER), said: “Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs.

“A case in point: no hydrocodone cough suppressant has been established as safe and effective for children under six years of age and some of these unapproved products carry labels with dosing instructions for children as young as two years of age.”

Copyright © PA Business 2007

CDER



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