FDA Week

FDA Call For Opana Withdrawal Sparks Debate Over Policy Implications

June 15, 2017
FDA's recent decision to request withdrawal of Endo Pharmaceuticals' opioid Opana Extended Release (ER) from the market has sparked debate between those concerned that pulling the opioid from the market could have a "chilling effect" on developers and those who say the product should never have been approved in the first place. On Thursday (June 8) FDA announced its request that Endo Pharmaceuticals remove Opana ER from the market "based on its concern that the benefits of the drug may...

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