WASHINGTON (dpa-AFX) - Endo International plc Thursday announced its decision to discontinue the sales of its opioid pain medication Opana ER.
The company said it made the voluntary decision to remove the drug from the market based on the Food and Drug Administration's request last month.
Opioids painkillers are very easy to get and are taken by too many people for far too long, according to U.S. health officials.
Endo expects an about $20 million pre-tax impairment charge in the second quarter 'to write-off the remaining net book value of its Opana ER intangible asset.' Opana ER sales amounted to about $160 million last year and nearly $36 million in the first quarter, the company said.
Endo also said that it continues to believe in the drug's safety and efficacy when used as intended.
Last month, FDA had asked Endo to remove Opana ER from the market, due to concern that the benefits of the drug may no longer outweigh its risks.
It is for the first time that the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse, the FDA said.
The FDA noted that its decision was based on a review of all available postmarketing data. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder.
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