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FDA halts marketing of certain unapproved narcotics

Executive Summary

Nine companies received FDA warning letters March 31 for manufacturing 14 unapproved narcotic drugs including high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. The companies cited include Boehringer Ingelheim Roxane; Cody Laboratories; Glenmark Pharmaceuticals; Lannett Company; Lehigh Valley Technologies; Mallinckrodt; Physician's Total Care; Roxane Laboratories; and Xanodyne. The warning letters were sent as part of FDA's initiative on marketed unapproved drugs (1"The Pink Sheet," June 12, 2006, p. 10)

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