FDA Asks Endo to Withdraw Opana ER Opioid

(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%.

“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

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

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

Endo Pharmaceuticals will work with the FDA to coordinate the organized removal of Opana ER from the U.S. market.

Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…

The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…

(Reuters)—Kentucky accused units of Endo International Plc. on Monday of contributing to drug overdoses by deceptively marketing its painkiller Opana ER, in the latest lawsuit by state or local governments against the drugmaker amid an opioid epidemic. Kentucky Attorney General Steve Beshear said the lawsuit would seek to hold Endo responsible for illegally building a…

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