The deadline set up for them to stop the shipments of such products across various states is November 26, this year. However, Friday's action does not affect products containing guaifenesin in immediate-release form, the FDA said.
The FDA says there are about 20 timed-release products that combine guaifenesin with a cough suppressant, or other drug, and the drugs are distributed by nearly 65 companies. Such medicine includes Guaifenex, from Ethex Corp.; Crantex, from Breckenridge Pharmaceutical; and Amibid, from Acavis.
The agency said there are no safety issues with guaifenesin, which has been used in medicines for decades as a drug stimulates removal of mucous from the lungs.
AP reports that only one company, Adams Respiratory Therapeutics Inc., currently has FDA approval to sell extended-release guaifenesin. After the FDA's Friday move, the shares of the Chester, New Jersey-based company were up 9.86 percent, to $44, in early afternoon trading.
Earlier, the FDA has sent warning letters in 2002 and 2003 to 18 manufacturers and 48 repackers and distributors of single-ingredient guaifenesin extended-release products. It warned them about the required of an approved application to sell their products.
According to the FDA, Crantex and Guaifenex are the largest selling names of unapproved, immediate-release guaifenesin medicines, as of 2006. Crantex's distributor, Breckenridge Pharmaceutical Inc., of Boca Raton, Florida., will follow the FDA order and halt distribution by the November deadline, a company official said.
