FDA takes action against unapproved guaifenesin products

June 4, 2007

Manufacturers of timed-release guaifenesin products that have not been FDA approved have 90 days to stop making the products and 180 days to cease shipping them.

Manufacturers of timed-release guaifenesin products that have not been FDA approved have 90 days to stop making the products and 180 days to cease shipping them. According to the agency, there are about 20 companies that make the products that have not undergone regulatory review. The only manufacturer that has properly obtained approval is Adams Respiratory Therapeutics, under the trade names Mucinex and Humabid, and OTC products including Mucinex-D and Mucinex-DM. This action is yet another effort on the part of the FDA to crack down on the marketing of unapproved drugs that has so far included the withdrawal of unapproved carbinoxamine-containing medications, trimethobenzamide suppositories, ergotamine drug products, and quinine sulfate. The recent action does not affect products containing immediate-release guaifenesin.

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