Endo Loses Bid to Stop Generic Version of Its Painkiller

Wall Street Journal
Drug maker Endo Health Solutions Inc. failed in its legal bid to halt generic versions of its Opana painkiller Wednesday, clearing the way for cheaper copies of the drug to appear in the U.S. as early as next month. The prospect of a new generic opioid painkiller has raised safety concerns because the pills are often abused. Endo reformulated Opana in March 2012 to make the pills harder to crush, snort or inject, and it withdrew the original formulation from the market. It asked the Food and Drug Administration to rule that the old Opana was withdrawn for reasons of safety, something that would block generic competitors from coming to market. Endo later filed a lawsuit against the FDA, contending the agency had failed to make a decision in a timely manner. Under the terms of a previous settlement, Impax Laboratories Inc. is due to be able to start selling several higher doses of extended-release oxymorphone, the generic name of Opana, in January.
Full Article >