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FDA moves against unapproved cold drugs

The US Food and Drug Administration has announced it is to take action against companies that market unapproved prescription oral cough, cold, and allergy products

The US Food and Drug Administration (FDA) has announced its intention to take enforcement action against companies that market unapproved prescription oral cough, cold, and allergy products. The agency noted that many healthcare providers prescribe the drugs without being aware that they lack official FDA approval.

In a Federal Register notice, the FDA said that actions against the companies could include product seizure and injunction, and that it did not intend to issue warning letters before taking such actions.

Companies that have previously listed the unapproved products with the FDA are now required to stop manufacturing them within 90 days and stop shipping within 180 days. Companies that have not previously listed the products are required to stop manufacturing and shipping immediately.

The FDA said some of the unapproved products may contain potentially risky combinations of ingredients, while others - marketed as "timed-release" - may release active ingredients at the wrong speed or inconsistently. In addition, some of the products have names that look or sound similar to other products, which could potentially lead to medication errors, while others are inappropriately labelled for use by infants and young children.

"Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed over-the-counter, taking an unapproved prescription product is an unnecessary risk," the FDA said.

The enforcement action is being taken under the FDA's Unapproved Drugs Initiative, which was launched in June 2006 and has already addressed the marketing of unapproved products in a number of other drug classes.

3rd March 2011

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