Endo Health Solutions Inc. lost a bid to stop competitors from selling a generic version of its painkiller drug Opana ER over claims that the drug poses a risk to the public.
U.S. District Judge Reggie Walton in Washington today dismissed Endo’s lawsuit against the U.S. Food and Drug Administration seeking an order declaring the original formulation of Opana ER unsafe because the pills could be crushed and snorted by drug abusers. Endo makes a new version of the medication.
Endo, which sought a preliminary injunction, asked Walton to order the FDA to suspend approval of any generic of Opana and block its sale until the agency makes a finding on the company’s claim that it withdrew the painkiller from the market for safety reasons.
Dave Holveck, president and chief executive officer of Endo Health Solutions, said in a statement that the company was “extremely disappointed” with the ruling.
“The launch of a generic non-crush-resistant version of Opana ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone,” he said.
Sandy Walsh, an FDA spokeswoman, didn’t immediately respond to an e-mail message seeking comment on the ruling.
Impax Laboratories Inc. and Actavis South Atlantic LLC are among producers of the generic Opana ER, Endo said in the complaint. Impax is scheduled to begin selling the drug next month, according to the complaint.
The opioid painkiller is the Chadds Ford, Pennsylvania-based company’s second-biggest product. On Nov. 5, Endo fell the most in almost four years after quarterly sales declined for the first time since 2006 and the company ended a study of a bladder cancer drug.
The case is Endo Pharmaceuticals Inc. v. U.S. Food and Drug Administration, 12-cv-01936, U.S. District Court, District of Columbia (Washington).