![]() Seeking Alpha reported the company’s shares fell 14% after FDA released its request. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients,” the company wrote. “Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. If Endo does not take steps to remove Opana ER from the market, the agency said it intends to move to withdrawal its approval.Įndo responded in a statement saying that it was reviewing FDA’s request. In a March 2017 advisory meeting, the agency voted 18–8 that the benefits associated with Opana ER no longer outweigh the risks. However, the agency said that data on the reformulated version of the drug did not appear to “meaningfully reduce abuse.” In addition, FDA said it has found that injection abuse of the reformulated Opana ER is associated with an outbreak of HIV and hepatitis C, as well as the blood disorder thrombotic microangiopathy. This is the first time the agency has requested a company remove an opioid from the market.Įndo reformulated Opana ER in 2012 with the intention of making it resistant to the physical and chemical manipulation consistent with abuse. In a Jpress release, the agency said it was requesting Endo “voluntarily remove” Opana ER from the market based on postmarketing data that indicated a “significant shift in the route of abuse” after the drug was reformulated. In an unprecedented statement, FDA asked Endo Pharmaceuticals to remove its opioid Opana ER (oxymorphone hydrochloride) from the market. In June 2017, the FDA requested that Endo Pharmaceuticals remove reformulated Opana ER from the market because the benefits no longer outweigh the risks. ![]()
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