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Endo Health Sues FDA Over Safety of Painkiller Opana

Endo Health Solutions Inc. sued the U.S. Food and Drug Administration seeking an order declaring the original formulation of its drug Opana ER unsafe, saying a generic version of the painkiller set for sale next month poses a risk to the public.

Endo, in a complaint filed today in federal court in Washington, said it stopped selling Opana ER after finding the pills could be crushed and inhaled by drug abusers. Endo replaced that version with a crush-resistant one, known as Opana ER CRF, in February.

“FDA knows from its own experience and public statements, and from data submitted by Endo, that the public health will be harmed substantially by introduction of a generic version of non-crush-resistant original formulation Opana ER,” David Goewey, a lawyer for Endo, said in the complaint.

Endo, which is seeking a preliminary injunction, asked the court to order the FDA to suspend approval of any generic versions of Opana until the agency makes a finding on the company’s claim that it withdrew the painkiller from the market for safety reasons.

Sandy Walsh, an FDA spokeswoman, said in an e-mail that the agency doesn’t comment on pending litigation.

Impax Laboratories Inc. and Actavis South Atlantic LLC are among producers of the generic Opana ER, Endo said in 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).

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