US FDA tackles unapproved drugs

The US Food and Drug Administration says it has negotiated a consent decree with one manufacturer of unapproved drugs and sent warning letters to four others. In June, the FDA issued a guidance document, Marketed Unapproved Drugs - Compliance Policy Guide (CPG), which makes clear that firms marketing drugs requiring the agency's approval must submit applications showing that their products are safe and effective before marketing those products.

As part of its ongoing effort against marketed unapproved drugs and consistent with the CPG, the FDA said that Syntho Pharmaceuticals and Intermax Pharmaceuticals (Syntho/Intermax), of Farmingdale, New York, and the companies' owners have signed a consent decree of permanent injunction that bars them from manufacturing, processing, packing, labeling and distributing cough-cold medications entitled: Coldec Tablets; Coldec D Tablets; Coldec TR Tablets; Dyphylline & Guaifenesin Tablets, USP; Guaidex PD Tablets; Guaidex D Tablets; Crantex LA Tablets; Migrazone Capsules; and Usept Tablets, an antiseptic for urinary tract infections, and any other drugs that not do have the FDA's gold standard approval, or do not meet current Good Manufacturing Practice requirements under the Act.

Syntho/Intermax manufactured and distributed drugs that lacked required FDA approval. Manufacturing problems at the firms included releasing products for distribution that did not meet specifications. Under the consent decree, the two groups must stop making and distributing drugs until the FDA determines that the companies fully comply with the cGMP requirements. The firms are also prohibited from marketing drug products that lack necessary FDA approval.