Onsolis Approval History beta

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

Onsolis consists of a dissolvable polymer film formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Onsolis is used for the management of breakthrough pain in patients with cancer.

FDA Approval History for Onsolis

DateArticle
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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