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Endo Announces FDA Advisory Committee Meeting For OPANA ER; date of July 29, 2016

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Additional Information

Additional Relevant Details As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act (PDUFA) date of July 29, 2016 for the OPANA® ER sNDA will not be met and the action on the supplement is expected to be taken by the FDA as soon as possible following the Advisory Committee meeting.
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Catalyst Date
Occurred on:
Aug 12, 2016
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Related Keywords Opana Er, Advisory Committee Meeting