Adams Respiratory Therapeutics, Inc. reports that the Food and Drug Administration (FDA) has announced that companies must stop manufacturing and distributing unapproved timed-release dosage forms containing guaifenesin.
FDA indicated that companies marketing unapproved products containing guaifenesin in timed- release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. A small amount of these products is expected to be available after these dates until supplies are exhausted.
Michael J Valentino, president and CEO commented, "We are extremely pleased with the FDA announcement. We have always believed that the FDA would take enforcement action against the unapproved prescription versions of our Mucinex DM and Mucinex D and remove them from the market in due course. Our initial review of this regulatory action is underway and we expect to be able to serve the additional market demand for our products as it develops."
Valentino added, "I would also like to recognize the FDA's determined effort to act on its new guidance, 'Marketed Unapproved Drugs - Compliance Policy Guide,' which was finalized last June. Since that time, the agency has been moving aggressively to implement this guidance policy and remove unapproved drugs from the market."
Adams is a specialty pharmaceutical company focused on the late-stage development, commercialisation and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders.