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Arymo ER Approval Status

  • FDA approved: No
  • 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 in development for the management of severe pain.

Development Status and FDA Approval Process for Arymo ER

DateArticle
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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