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Fentora Approval History

  • FDA approved: Yes (First approved September 25th, 2006)
  • Brand name: Fentora
  • Generic name: fentanyl
  • Dosage form: Buccal Tablets
  • Previous name: OraVescent Fentanyl
  • Company: Cephalon, Inc.
  • Treatment for: Pain

Fentora is an effervescent buccal formulation of the potent opioid analgesic fentanyl, indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Development History and FDA Approval Process for Fentora

Sep 25, 2006Approval Fentora Cephalon, Inc. - Treatment for Breakthrough Pain in Patients with Cancer
Jun 29, 2006Cephalon Receives Approvable Letter for Fentora (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer
Sep  6, 2005Cephalon Files New Drug Application for OraVescent Fentanyl for the Management of Breakthrough Pain in Cancer Patients

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