Friday, July 7, 2017
Endo International plc continues to believe in the safety, efficacy, and favorable benefit-risk profile of OPANA® ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company 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, the Company 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.