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 FDA request made in June

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