Subsys Approval History

  • FDA approved: Yes (First approved January 4th, 2012)
  • Brand name: Subsys
  • Generic name: fentanyl
  • Company: INSYS Therapeutics, Inc.
  • Treatment for: Pain

Subsys (fentanyl) is an opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.

FDA Approval History for Subsys

DateArticle
Jan  5, 2012Approval Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray
May 21, 2011INSYS Announces NDA PDUFA Date for Fentanyl SL Spray

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