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FDA pulls opioid from market over misuse concerns

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2860 (Published 13 June 2017) Cite this as: BMJ 2017;357:j2860
  1. Owen Dyer
  1. Montreal

The US Food and Drug Administration has asked Endo Pharmaceuticals to withdraw its Opana ER formulation of oxymorphone amid concerns over a mounting epidemic of opioid misuse. It is the first time the FDA has made such a request, which could require court action to enforce.

The Dublin based drug manufacturer did not immediately say whether it would comply. Endo said in a statement that it is “reviewing the request and is evaluating the full range of potential options.”

The FDA’s request sent Endo’s shares tumbling 13.4% on Wall Street. The request was foreshadowed in March, when an FDA …

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