“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. Endo reformulated Opana ER in a way that the company said would curb the potential for abuse, but an FDA advisory committee voted 18-8 (with one abstention) in mid-March that the benefits of the reformulated version no longer outweigh risks of the drug. The FDA said in its statement that if Endo does not meet its request, it will take steps to withdraw approval of the drug, prescribed when someone needs a long-term pain medication. The request comes as the United States finds itself in the middle of what the federal Department of Health and Human Services describes as an “unprecedented opioid epidemic.” More people died in 2014, the most recent year for which data is available, from drug overdoses than any other year on record and more than 60% of those deaths involved an opioid, the federal government says.Īs word of the FDA request circulated, shares of Endo International dipped almost 13% to $11.99 on Thursday. Endo has global headquarters in Dublin but a U.S. The FDA is asking Ireland-based Endo Pharmaceuticals to stop selling reformulated Opana ER, or oxymorphone hydrochloride, because the risks outweigh any benefits of pain control, the FDA said in a statement Thursday. Food and Drug Administration is asking that a pharmaceutical company withdraw a currently marketed opioid pain medication because of the drug’s potential for abuse.
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