Endo Pulls Opioid From US Market at FDA’s Request

Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request remove its opioid Opana ER (oxymorphone hydrochloride extended-release) from the US market.

FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after “a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.”

As a result, the Dublin-based company said it expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017. Net sales of Opana ER in 2016 were $158.9 million.

Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request remove its opioid Opana ER (oxymorphone hydrochloride extended-release) from the US market. FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after “a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.” As a result, the Dublin-based company said it expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017. Net sales of Opana ER in 2016 were $158.9 million.

Read the full article at: raps.org