FDA Sets Deadline for Unapproved Medications

Manufacturers of unapproved extended-release cough and cold drugs that contain an expectorant called guaifenesin have until Nov. 25 to stop shipping the medications, health officials said yesterday.

The Food and Drug Administration said that roughly 20 companies make hundreds of time-release medications containing guaifenesin that have never undergone agency review. They are expected to stop making the drugs by Aug. 27. The drugs are sold by prescription and over the counter, and as both single-ingredient and combination products.

Yesterday's action does not affect products containing guaifenesin in immediate-release form, the FDA said. The agency said that it knew of no safety issues with guaifenesin, which has been used in medications for decades. The drug stimulates removal of mucus from the lungs.

Only one company, Adams Respiratory Therapeutics Inc., has FDA approval to sell extended-release guaifenesin. In 2002, the FDA approved single-ingredient versions of the medications, sold as Mucinex and Humibid. A year later, the FDA approved combination versions of Mucinex that included either a cough suppressant or decongestant.

Also in 2002, the FDA sent warning letters to 18 manufacturers and 48 repackers and distributors of single-ingredient guaifenesin extended-release products, telling them that they required an approved application to sell their products. It warned them again in 2003.

The FDA identified Crantex and Guaifenex as among the biggest-selling names of unapproved, immediate-release guaifenesin medications, as of 2006.

Crantex's distributor, Breckenridge Pharmaceutical Inc. of Boca Raton, Fla., will comply with the FDA and halt distribution by the November deadline, said Larry Lapila, vice president of business development. A message left with Ethex Corp., the St. Louis company that distributes Guaifenex, was not returned.