Under pressure from the US Food and Drug Administration, Ireland-incorporated Endo International (Nasdaq: ENDP) has agreed to voluntarily withdraw its opioid pain drug Opana ER (oxymorphone hydrochloride extended release) from the US market.
A month ago, the FDA called on Endo to remove its drug from the market, causing a 13.6% drop to $11.90 on June 8, and the shares fell a further 1.9% to $11.17 by close of trading Thursday.
Endo says it continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER 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 agency’s withdrawal request, the company has decided to voluntarily remove Opana ER from sale.
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