Subsys 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 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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