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FDA Seeks Stronger Safeguards For Addictive Opioids

Law360 (February 9, 2009, 12:00 AM EST) -- The U.S. Food and Drug Administration has ordered 16 U.S. drug companies, including Ortho-McNeil-Janssen Pharmaceuticals Inc., Actavis Group and Teva Pharmaceuticals USA Inc., to develop strong measures to prevent the misuse and abuse of addictive opioid painkillers.

The agency sent letters Friday to the pharmaceutical giants indicating that 24 brand-name and generic prescription drugs, including morphine, oxycodone and methadone, will be required to have a Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drugs continue to outweigh the risks, the FDA announced...
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