When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.” “We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, M.D. 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. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. See Also: Why Kezar Life Sciences Stock Is Soaring TodayĮNDP Price Action: Endo International has traded between $7.06 and 28 cents over a 52-week period.Today, the U.S. ![]() ![]() ![]() "The Constitution does not confer a right to abortion Roe and Casey are overruled and the authority to regulate abortion is returned to the people and their elected representatives," the Supreme Court syllabus said. Nearly 50 years later, that right has been eliminated. The court’s controversial decision will allow individual states to make their own abortion laws. Wade ruling established the constitutional right to abortion. Plan-B is a type of emergency birth control, often referred to as "the morning-after pill." Wade decision.Įndo International subsidiary Paladin Labs has a group of brands, including Plan-B, that it has acquired or licensed for use in Canada. Supreme Court ruling, which overturned the Roe v. Endo International Plc ENDP shares continue to trade higher Tuesday in possible reaction to a recent U.S.
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