FDA blocks unapproved narcotics marketing

31 March 2009

The US Food and Drug Administration has blocked the marketing of 14 unapproved narcotic drugs that are sold in several dosage forms and are  widely used to treat pain. Nine firms were ordered to stop manufacturing  the products.

The FDA's warning letters notified the companies they may be subject to  enforcement action if they do not stop manufacturing and distributing  prescription unapproved products that include high-concentrate morphine  sulfate oral solutions and immediate-release tablets containing  morphine sulfate, hydromorphone or oxycodone. This action does not  include oxycodone capsules, the agency explained.

Companies receiving warning letters were: Boehringer Ingelheim Roxane,  based in Columbus, Ohio; Cody Laboratories, based in Cody, Wyoming;  Mahwah, New Jersey-headquartered Glenmark Pharmaceuticals, Lannett  Company, of Philadelphia, Pennsylvania; Lehigh Valley Technologies, of  Allentown, Pennsylvania; Mallinckrodt Pharmaceuticals Group, of St  Louis, Missouri; Physicians Total Care based in Tulsa, Oklahoma; Roxane  Laboratories, of Columbus, Ohio; and Xanodyne Pharmaceuticals of  Newport, Kentucky.

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