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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