Endo Removes Opioid from Market Per FDA Request

Jul 06, 2017

Endo International released a statement that it continues to believe in the safety, efficacy and favorable benefit-risk profile of OPANA ER (oxymorphone hydrochloride extended release) when used as intended. The company says it has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the company has decided to voluntarily remove OPANA ER from the market.

As a result, Endo expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017 to write-off the remaining net book value of its OPANA ER intangible asset. Reported net sales of OPANA ER were $158.9 million for full-year 2016 and $35.7 million for first quarter 2017.

Endo plans to work with FDA to coordinate the orderly removal of OPANA ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals. Patients should discuss treatment options with their prescribing physician at their next visit.

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