Drug Safety
U.S. Food and Drug Administration acts to improve drug safety and quality
Published in Medical Letter on the CDC and FDA, July 16th, 2006
The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children under 2 years of age. The agency is issuing a final guidance document outlining its approach to addressing other medicines that are marketed without FDA approval.
The first action under the new guidance, "Marketed Unapproved Drugs--Compliance Policy Guide," concerns carbinoxamine-containing products. Carbinoxamine-containing products require FDA approval to be marketed, but numerous...
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