Production of unapproved carbinoxamine items to cease

June 19, 2006

The FDA has ordered manufacturers of all unapproved carbinoxamine-containing products to stop producing their offerings over the next 30 to 90 days. The agency has received 21 reports of death in children under two years of age associated with these products.

Production of unapproved carbinoxamine items to cease

The FDA has ordered manufacturers of all unapproved carbinoxamine-containing products to stop producing their offerings over the next 30 to 90 days. The agency has received 21 reports of death in children under two years of age associated with these products. While it is not clear whether the antihistamine itself caused the deaths, the FDA is concerned about the risks of unapproved drugs, some of which are being promoted for infants and young children, the agency said. In order to resume marketing of these products, drugmakers must submit applications to the agency showing that they are safe and effective. The FDA is issuing a guidance entitled "Marketing Unapproved Drugs-Compliance Policy Guide" to address the issue and will prioritize enforcement actions against illegally marketed drugs. The action will not affect products manufactured by Mikart Inc., which are the only carbinoxamine products approved by the FDA. The 4-mg tablet and 4 mg/5 ml oral solution are sold under the trade name Palgic.

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