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You are here: Home / Articles / FDA Asks Endo to Withdraw Opana ER Opioid

FDA Asks Endo to Withdraw Opana ER Opioid

June 10, 2017 • By Reuters Staff

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(Reuters)—The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company’s shares down as much as 13%.

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“After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks,” the agency said in a statement.1

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It is the first time the agency has taken steps to remove an opioid pain medication due to the public health implications of abuse.


Reference

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  1. U.S. Food and Drug Administration. News release: FDA requests removal of Opana ER for risks related to abuse. 2017 Jun 8.

Filed Under: Analgesics, Drug Updates

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  • FDA Says It Requires Boxed Warning on Some Opioid-Based Painkillers

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