Endo gives in to FDA demand and agrees to yank its opioid painkiller

Stat News

7 July 2017 - In the end, the executive team at Endo International blinked.

The drug maker has voluntarily agreed to withdraw its Opana ER opioid painkiller in response to an unusual request last month from the Food and Drug Administration over concerns the pill is too easily abused.

The agency move, which came amid a worsening epidemic of deaths and overdoses attributed to opioids, drew widespread notice because the FDA had never taken such a step before. Moreover, Endo appeared to balk at withdrawing the pill and released a statement saying it was “reviewing the request and is evaluating the full range of potential options.”

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Withdrawal