FDA requests removal of Opana ER for risks related to abuse
The US Food and Drug Administration on Thursday called on Endo Pharmaceuticals (Nasdaq: ENDP) to voluntarily remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market.
Endo’s shares plunged 13.6% to $11.90 in after-hours trading on Thursday, having closed normal trading up 11.3% at $13.78.
After careful consideration, the FDA says it is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.
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