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CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.
The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.
Endo launched a reformulated version of Opana ER designed to be crush-resistant in March 2012, but the court's ruling allows a generic, nontamper-resistant version to be launched on Jan. 2, 2013. The court ruled that the FDA had not unduly delayed making a determination, which it plans to do by May 2013.
"We are extremely disappointed by today's decision," Endo president and CEO Dave Holveck said. "Despite the fact that the generic product will not be therapeutically equivalent to the crush-resistant formulation, the launch of a generic noncrush-resistant version of Opana ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone. We are hopeful that the FDA will ultimately make the right decision before May in light of the surveillance data supporting that the original formulation of Opana ER was discontinued for reasons of safety."