The maker of opioid painkiller Opana ER is pulling the drug off the market at the request of federal regulators because it’s being abused. Endo International PLC said Thursday it will voluntarily stop selling the pills, approved for use in patients with severe, constant pain, after consulting with the U.S. Food and Drug Administration. It’s…
FDA Asks Drugmaker To Stop Selling Its Opioid Painkiller
U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it. The Food and Drug Administration said Thursday it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER, after concluding the drugs’s risks outweigh its benefits. It’s the first time…
FDA Further Restricts Pain Medication Use In Kids
U.S. regulators are strengthening warnings about the dangers of two types of powerful painkillers due to risks of slowed breathing and death. The Food and Drug Administration said Thursday it is requiring makers of prescription versions of the medicines, codeine and tramadol, to change the products’ labels to warn against giving them to children under…
Mallinckrodt To Pay $35 Million In Deal To End Feds’ Opioid Probe
A top maker of brand-name and generic narcotic painkillers has agreed to pay the U.S. government $35 million to resolve a probe of its distribution of those drugs. Mallinckrodt PLC said Monday it has reached an agreement with the U.S. Drug Enforcement Administration and the U.S. attorneys for the Eastern District of Michigan and Northern…