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Subsys Approval History

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

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

Development History and FDA Approval Process for Subsys

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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