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October 5, 2006

Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:


FDA Continues To Tackle Unapproved Drugs

The U.S. Food and Drug Administration (FDA) has negotiated a consent decree with one manufacturer of unapproved drugs and sent warning letters to four others. In June, 2006 FDA issued a guidance document, "Marketed Unapproved Drugs -- Compliance Policy Guide" (CPG). This CPG makes clear that firms marketing drugs requiring FDA approval must submit applications showing that their products are safe and effective before marketing those products.

As part of FDA's ongoing effort against marketed unapproved drugs and consistent with the CPG, FDA announced that Syntho Pharmaceuticals, Inc., and Intermax Pharmaceuticals, Inc. (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 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, Syntho/Intermax must stop manufacturing and distributing drugs until FDA determines that the firms fully comply with the current good manufacturing practice (CGMP) requirements. The firms are also prohibited from marketing drug products that lack necessary FDA approval.

In addition, to ensure that Syntho/Intermax's products already in distribution are no longer used by consumers, FDA requested that Syntho/Intermax recall all unapproved drugs and drugs that they have manufactured and distributed with poor manufacturing standards. FDA is advising consumers who have used these firms' products and have concerns or questions to contact their physician or health care practitioner.

This action is an example of FDA's ongoing effort against marketed unapproved drug products, and it follows similar enforcement actions. For example, in July, 2005, after FDA inspections and a trial in federal court, Pharmakon Labs, Inc., as well as its president and secretary/treasurer, were ordered to stop manufacturing and distributing drugs until Pharmakon complied with CGMP requirements and obtained FDA approval for manufacturing and distributing drug products.

FDA also recently sent warning letters to a number of firms manufacturing unapproved drugs under conditions that do not meet CGMP requirements. These firms are: Neil Laboratories, East Windsor, NJ; Concord Laboratories Inc., Fairfield, NJ; Scientific Laboratories, Columbia, MD; and Sheffield Laboratories, New London, CT. Copies of these warning letters can be found at: www.fda.gov/foi/warning.htm.

Information on FDA's ongoing efforts regarding marketed unapproved drugs can be found at: www.fda.gov/cder/drug/unapproved_drugs/.

"These actions demonstrate the agency's continued commitment to tackling the unapproved drugs problem," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. “Unapproved drugs are a public health concern because they may not meet modern standards for safety, effectiveness, quality, and labeling."

The CPG on Marketed Unapproved Drugs is part of FDA's broader initiative, launched last year, to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs. The CPG outlines FDA's program to bring drugs that lack required approval into the agency's approval process. FDA gives highest priority to enforcement actions involving unapproved drugs that pose a risk to the public health, and to drugs that lack evidence of effectiveness, constitute health fraud, or threaten the integrity of the drug approval process. FDA's CPG also warns that the agency may target specific firms whose products, in addition to lacking required approval, violate other parts of the federal Food, Drug, and Cosmetic Act such as CGMP requirements.


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