The US FDA’s decision to seek market withdrawal of Endo Pharmaceuticals Inc.’s Opana ER (oxymorphone extended-release) due to intravenous abuse liability builds upon earlier regulatory actions on two Purdue Pharma LP opioid products and may be the beginning a new level of scrutiny for opioid product formulations with high risk of abuse.
The agency’s 2005 request that Purdue withdraw Palladone (hydromorphone extended-release) due to the risk of dose-dumping in the presence of alcohol and its 2013 conclusion that the original formulation of OxyContin (oxycodone extended-release) was removed from the market
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