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Arymo ER Approval History

  • FDA approved: Yes (First approved January 9th, 2017)
  • Brand name: Arymo ER
  • Generic name: morphine sulfate
  • Dosage form: Extended-Release Tablets
  • Company: Egalet Corporation
  • Treatment for: Pain

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation for the management of severe pain.

Development History and FDA Approval Process for Arymo ER

Jan  9, 2017Approval FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain
Oct 13, 2016Egalet Notified that FDA Will Not Meet PDUFA Goal Date for Arymo ER
Aug  4, 2016Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent Arymo ER (Morphine Sulfate)
Feb 29, 2016Egalet Announces FDA Acceptance of New Drug Application for Arymo ER (Morphine Sulfate) Extended-Release Tablets
Dec 15, 2015Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets

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