Endo Health Sues FDA Over Safety of Opioid Painkiller Opana
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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.