Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
Endo Pharmaceuticals will work with the FDA to coordinate the organized removal of Opana ER from the U.S. market.
The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
(Reuters)—The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company’s shares down as much as 13%. “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer…
(Reuters)—Delaware on Friday became the latest state to file a lawsuit accusing corporations of helping fuel the national opioid epidemic, suing a wide range of companies involved in making, distributing and selling prescription painkillers.1 The lawsuit, filed by Delaware Attorney General Matt Denn in a state court, targeted drugmakers Purdue Pharma LP and Endo International…
NEW YORK (Reuters)—Makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives, the course  said on Thursday. The FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses…
(Reuters)—Missouri on Wednesday became the third U.S. state to accuse major drug manufacturers of fraudulently misrepresenting the risks of opioid painkillers now at the center of a national addiction epidemic. Missouri Attorney General Josh Hawley said his office filed a lawsuit in a state court in St. Louis against Purdue Pharma LP, Johnson and Johnson…
In March, an FDA advisory committee voted that the risks of Opana ER to public health outweigh its benefits as a chronic pain treatment…
(Reuters)—Kentucky’s attorney general on Monday accused drug distributor McKesson Corp. of helping fuel the opioid epidemic by failing to halt shipments of suspiciously large or frequent orders by pharmacies of prescription painkillers. The complaint by Kentucky Attorney General Andy Beshear was filed in a state court and was one of a flurry of lawsuits by…
(Reuters)—Kentucky accused units of Endo International Plc. on Monday of contributing to drug overdoses by deceptively marketing its painkiller Opana ER, in the latest lawsuit by state or local governments against the drugmaker amid an opioid epidemic. Kentucky Attorney General Steve Beshear said the lawsuit would seek to hold Endo responsible for illegally building a…