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Opana Withdrawal Request Builds On US FDA Actions On Palladone, OxyContin

 
• By Sue Sutter

Earlier withdrawals of Purdue’s Palladone and original OxyContin create precedent for request that Endo’s Opana ER come off market due to risk of abuse; former chief counsel sees agency's move as ‘tip of the iceberg’ on opioid safety actions.

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...

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