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Fentora FDA Approval History

FDA Approved: Yes (First approved September 25, 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 timeline 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

Further information

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