FDA issues final guidance on unapproved drugs

June 12, 2006

The FDA has issued a final guidance outlining the steps the agency will take to address medicines that are marketed without FDA approval. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children less than two years of age.

FDA issues final guidance on unapproved drugs

The FDA has issued a final guidance outlining the steps the agency will take to address medicines that are marketed without FDA approval. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children less than two years of age. To date, the FDA has approved two carbinoxamine products for various allergic symptoms. Many unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, an indication for which carbinoxamine has not been found safe and effective by the FDA. The agency estimates that there are several hundred different unapproved active ingredients in prescription drugs on the market, with less than 2% of prescribed drugs being unapproved. Many of the unapproved drugs affected by the final guidance are medicines that were developed and marketed before successive changes to the drug approval process, which was established in the Federal Food, Drug, and Cosmetic Act. Under the new guidance, Marketed Unapproved Drugs-Compliance Policy Guide, the FDA is encouraging companies to comply with the drug approval process and seek approval for their products, as well as safeguard consumer access to important medicines. "Unapproved drugs may not meet modern standards for safety, effectiveness, quality, and labeling," said Steven Galson, M.D., director of the FDA Center for Drug Evaluation & Research during a press telebriefing. "This has been a concern of the agency over the past few years and will be a significant effort for us going forward."

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