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Onsolis Approval History

  • FDA approved: Yes (First approved July 16th, 2009)
  • Brand name: Onsolis
  • Generic name: fentanyl
  • Dosage form: Buccal Soluble Film
  • Previous name: BEMA Fentanyl
  • Company: BioDelivery Sciences International, Inc.
  • Treatment for: Pain

Onsolis (fentanyl) is an opioid agonist in a buccal formulation indicated for the management of breakthrough pain in cancer patients.

Development History and FDA Approval Process for Onsolis

Aug 13, 2015Approval BioDelivery Sciences Announces FDA Approval of New Formulation of Onsolis (fentanyl buccal soluble film) CII
Jul 16, 2009Approval BioDelivery Sciences and Meda Announce FDA Approval of Onsolis
Jun 15, 2009BioDelivery Sciences Provides NDA Update for Onsolis
Dec 15, 2008BioDelivery Sciences Submits REMS for Onsolis to FDA for Approval
Nov  7, 2008BioDelivery Sciences to Meet with FDA to Finalize Proposed REMS for Onsolis
Aug 28, 2008BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA Fentanyl (Onsolis)
Jan 10, 2008FDA Accepts for Filing the BEMA Fentanyl NDA from BioDelivery Sciences
Oct 31, 2007BioDelivery Sciences Submits NDA For BEMA Fentanyl

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