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.
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Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.
Instead of creating new mandate, legislation tells FDA to outline how risk-benefit decisions could be influenced by a product's abuse potential under existing approval authority; final opioids package expected to reach the White House soon.