Subsys FDA Approval History
FDA Approved: Yes (First approved January 4, 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 timeline for Subsys
| Date | Article |
|---|---|
| Jan 5, 2012 | Approval Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray |
| May 21, 2011 | INSYS Announces NDA PDUFA Date for Fentanyl SL Spray |
Further information
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