Article: FDA acts to improve drug safety and quality; FDA strengthens its efforts on unapproved prescription drug products containing carbinoxamine.

M2 PRESSWIRE-8 June 2006-US FDA: FDA acts to improve drug safety and quality; FDA strengthens its efforts on unapproved prescription drug products containing carbinoxamine(C)1994-2006 M2 COMMUNICATIONS LTD

RDATE:08062006

The Food and Drug Administration (FDA) announced the strengthening of its efforts against unapproved drug products.

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 ...

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