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Symproic Approval History

  • FDA approved: Yes (First approved March 23rd, 2017)
  • Brand name: Symproic
  • Generic name: naldemedine
  • Dosage form: Tablets
  • Company: Shionogi Inc.
  • Treatment for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

Development History and FDA Approval Process for Symproic

DateArticle
Mar 23, 2017Approval FDA Approves Symproic (naldemedine) for the Treatment of Opioid-Induced Constipation
Jun  6, 2016Shionogi Announces Acceptance of NDA for Naldemedine for the Treatment of Opioid-Induced Constipation
Mar 30, 2016Shionogi Submits New Drug Applications in Japan and the U.S. for Naldemedine for the Treatment of Opioid-Induced Constipation

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