The FDA, which estimated there are several hundred unapproved active ingredients in prescription drugs on the market, issued a new guidance that encourages companies marketing unapproved drugs to seek agency approval.
"Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Acting FDA Commissioner Andrew von Eschenbach.
The FDA said its first action would be focused on unapproved prescription products containing the antihistamine carbinoxamine.
Many unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, which is not an FDA approved indication for the compound. These products often are specifically labeled for use in young children, but this raises safety concerns because the drug has never been studied in this age group, the FDA said.
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