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The FDA has announced that it is strengthening the controls designed to protect patient safety by restricting imports of certain prescription drugs.
The Food and Drug Administration has announced that it is strengthening the controls designed to protect patient safety by restricting imports of certain prescription drugs.
The FDA's action involves adding the drugs to an existing FDA Import Alert, which warns FDA field personnel of the possible importation of these drugs, provides guidance as to their detention and refusal of admission into the United States, and advises customs personnel to refer any attempted importation to the local FDA field office.
The drugs added to the import alert are:
•Â AccutaneÂ® (isotretinoin), manufactured by Nutley, NJ-based Hoffmann-La Roche.
•Â ActiqÂ® (fentanyl citrate), manufactured by West Chester, PA-based Cephalon Inc.
•Â ClozarilÂ® (clozapine), manufactured by East Hanover, NJ-based Novartis Pharmaceuticals Corp.
•Â LotronexÂ® (alosetron hydrochloride), manufactured by Research Triangle Park, NC-based GlaxoSmithKline.
•Â MifeprexÂ® (mifepristone or RU-486).
•Â ThalomidÂ® (thalidomide), manufactured by Warren, NJ-based Celgene Corp.
•Â TikosynÂ® (dofetilide), manufactured by New York-based Pfizer Inc.
•Â Tracleerâ¢ (bosentan), manufactured by Allschwil, Switzerland-based Actelion Ltd.
•Â TrovanÂ® (trovafloxacin mesylate or alatrofloxacin mesylate injection), manufactured by Pfizer.
•Â XyremÂ® (sodium oxybate), manufactured by Orphan Medical, Minnetonka, MN.
According to the FDA, the agency's new commissioner has set reduction of preventable adverse events as a major priority for the agency and sees reducing unauthorized imports as a good place to start. "The FDA is committed to taking action, through educational activities and other means where necessary, to improve patient safety," said FDA Commissioner Mark B. McClellan. "Use of these FDA-approved products without adequate controls or monitoring, and using versions of these products not approved by FDA, increases the risk of serious adverse events for patients who might otherwise benefit from the drugs' use." PR