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Bunavail FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (Discontinued) (First approved June 6, 2014)
Brand name: Bunavail
Generic name: buprenorphine and naloxone
Dosage form: Buccal Film
Company: BioDelivery Sciences International, Inc.
Treatment for: Opioid Use Disorder

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

Development timeline for Bunavail

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

Further information

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