TWO FIRMS SHOULD RECALL UNAPPROVED DRUGS, FDA SAYS

The FDA announced a crackdown on two companies' marketing of unapproved drugs, including a consent decree prohibiting them from continuing the practice and a request by the agency to recall all they have already sold.

In addition to the action against Syntho Pharmaceuticals and Intermax Pharmaceuticals, the agency said Oct. 5 it sent warning letters to four other firms as part of its ongoing effort against marketed unapproved drugs.

Syntho and Intermax manufactured and distributed drugs without the required FDA approval, the agency said, adding that the products also did not meet current good manufacturing practices (cGMP).

The agency's agreement with the companies is a permanent injunction preventing Syntho and Intermax from manufacturing, processing, packing, labeling and distributing several cough-cold medications and an antiseptic for urinary tract infections. Syntho and Intermax must also stop manufacturing and distributing drugs until the FDA determines they comply with cGMP requirements.

A guidance document issued by the FDA in June 2006, "Marketed Unapproved Drugs -- Compliance Policy Guide," says firms whose drugs require FDA approval must submit applications showing their products are safe and effective before marketing those products.

The new warning letters were issued to Neil Laboratories, Concord Laboratories, Scientific Laboratories and Sheffield Laboratories. Neil would not comment on the warning letter, Concord and Sheffield could not be reached for comment by press time and no number was listed for Scientific Laboratories.