Bunavail Approval History

  • FDA approved: Yes (First approved June 6th, 2014)
  • Brand name: Bunavail
  • Generic name: buprenorphine and naloxone
  • Company: BioDelivery Sciences International, Inc.
  • Treatment for: Opiate Dependence

Bunavail (buprenorphine and naloxone) buccal film is an opioid analgesic/opioid antagonist formulation for the maintenance treatment of opioid dependence.

FDA Approval History for Bunavail

DateArticle
Jun  9, 2014Approval FDA Approves Bunavail Buccal Film for the Maintenance Treatment of Opioid Dependence
Oct 14, 2013BioDelivery Sciences Announces FDA Acceptance of Bunavail NDA for Filing

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