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