The agency says it plans to take action against companies that market unapproved drugs in timed-release dosage form containing guaifenesin, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs.

Approximately 20 firms make timed-release products containing guaifenesin that have not undergone FDA review and as a result are considered by the agency to be unapproved drugs. This doesn’t affect products containing guaifenesin in immediate release form, by the way.

Timed-release drugs require FDA approval because the agency must ensure that the product releases its active ingredients safely and effectively, sustaining the intended effect over the entire time in which the med is supposed to work.

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.

To date, only Adams Respiratory Therapeutics has obtained FDA approval for timed-release products containing guaifenesin under the trade names of Mucinex and Humibid. Adams stock is up nearly 10 percent so far today on the news.

Further reading…
FDA statement;
[tags]Adams Respiratory Therapeutics, Guaifenesin[/tags]