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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

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

Further information

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