February 20, 2018
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Endo to pull opioid painkiller off US market after FDA nudge

By Reuters

Endo International Plc agreed on Thursday to remove its long-acting opioid painkiller from the U.S. market to comply with the health regulator’s request last month, sending its shares down as much as 3 percent.

Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.

The U.S. Food and Drug Administration in June had requested the withdrawal of Endo’s Opana ER, marking the first time the agency asked for an opioid painkiller to be taken off the market for public health reasons.

The regulator’s request followed the recommendation of an independent panel of advisers, which concluded that the drug’s benefits no longer outweighed its risks.

Endo on Thursday said it expects to incur a pre-tax impairment charge of about $20 million in the second quarter, and plans to work with the FDA to coordinate the drug’s orderly removal.

The painkiller, which was initially approved in 2006, generated sales of about $159 million in 2016.

A growing body of litigation is piling up against manufacturers of opioid painkillers over claims that drugmakers, including Endo, misrepresented the risks of addiction, overdose and abuse associated with these medicines.

Endo’s shares were down about 2.3 percent at $11.13 in late-afternoon trading.

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