1. Pink Sheet

Curtain Falls On Opana ER As Endo Agrees To US FDA Withdrawal Request

 
• By Sue Sutter

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.

People running from dangerous pills

Endo International PLC's decision to withdraw the long-acting opioid Opana ER (oxymorphone extended-release) from the US market avoids a big fight with FDA over a product that represented little in the way of sales.

On July 6, Endo said it would voluntarily withdraw the current Opana ER formulation from the market pursuant to an...

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