FDA cracks down on guaifenesin-TR sale

In a statement issued on May 25, the US Food and Drug Administration says it has taken action to stop the sale of unapproved timed-release versions of the cough medicine guaifenesin. The agency said that it intends to bring legal action against companies that market such products.

The immediate-release formulation of guaifenesin, which is an orally-delivered expectorant, was first approved by the FDA in 1952, and has since been included in over-the-counter cough medications. To date, however, only Adams Respiratory Therapeutics has received clearance to sell an extended-release version of the drug under the trade names Mucinex and Humibid (Marketletter August 28, 2006).

The FDA said that it expects firms that market unapproved products which contain guaifenesin TR, thought to be around 20 companies in total, to cease production within 90 days and stop shipping the product across state lines in the next 180 days. The agency said that, after this date, drugmakers wishing to sell guaifenesin-containing products must obtain approval or face regulatory action.