Opana Withdrawal Request Builds On US FDA Actions On Palladone, OxyContin
Executive Summary
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.
You may also be interested in...
A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
Curtain Falls On Opana ER As Endo Agrees To US FDA Withdrawal Request
Company will cease manufacturing the extended-release oxymorphone formulation immediately and will not ship existing finished product after Sept. 1; decision to pull the opioid from the market heads off a fight with FDA, which sought withdrawal due intravenous abuse liability.
Opana ER Should Come Off The US Market, FDA Tells Endo
Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.