Catalyst

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Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent ARYMO ER (Morphine Sulfate) and Reports Second Quarter 2016 Financial Results

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EGLT

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Additional Information

Additional Relevant Details The committees also voted:
  • 16 to 3 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the oral route of abuse;
  • 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the nasal route of abuse; and
  • 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.
http://egalet.invest...
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Catalyst Date
Occurred on:
Aug 04, 2016
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Related Keywords Arymo Er, Morphine Sulfate