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FDA targets unapproved cough-cold, allergy drugs with Unapproved Drugs Initiative

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

The products include a wide range of drugs with active ingredients ranging from guaifenesin to dextromethorphan to pseudoephedrine hydrochloride, which also appear in a number of FDA-approved prescription and over-the-counter products. The agency said that many healthcare providers didn’t know the drugs didn’t have FDA approval because they lacked any labels indicating they didn’t.

“Removing these unapproved products from the market will reduce potential risks to consumers,” FDA Office of Compliance director Deborah Autor said. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough-cold and allergy symptoms; so we expect little or no negative impact on consumers from the removal of these unapproved products.”

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