10th Circ. Upholds FDA Win In Morphine Exemption Suit

Law360, New York (November 3, 2011, 4:41 PM EDT) -- The Tenth Circuit on Thursday affirmed a victory for the U.S. Food and Drug Administration, upholding the dismissal of drugmaker Lannett Co. Inc.'s claim that a 150-year-old version of morphine was exempted from FDA approval by federal law.

A three-judge panel ruled that because Lannett and subsidiary Cody Laboratories Inc. can still petition the FDA to review its decision to consider their morphine sulfate product an unapproved new drug, they have not exhausted their administrative remedies, and a court can dismiss the suit.

Lannett and Cody...
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