FDA takes action against unapproved guaifenesin products
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.
To see more Hot off the Press news articles, click here.
To go to the Drug Topics homepage, click here.
Pharmacists Play Unique Role in Advancing Health Equity for Patients With Chronic Disease
December 7th 2023A new study, outlined in a poster at ASHP Midyear 2023, identified 3 key themes associated with the ways in which pharmacists are positioned to advance health equity for patients with chronic diseases.
