Remoxy Review Shows How Opana ER Experience Changed US FDA Thinking On New Opioid Formulations

Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.

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What the US FDA sees as new and emerging methods of manipulation to defeat abuse-deterrent formulations, Pain Therapeutics sees as moving the goalposts for regulatory approval.

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