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Probuphine FDA Approval History

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

FDA Approved: Yes (First approved May 26, 2016)
Brand name: Probuphine
Generic name: buprenorphine
Dosage form: Implant
Company: Titan Pharmaceuticals, Inc.
Treatment for: Opioid Use Disorder

Probuphine (buprenorphine) is an opioid partial agonist subdermal implant for the treatment of opioid dependence.

Development timeline for Probuphine

May 26, 2016Approval FDA Approves Probuphine (buprenorphine) Implant for Treatment of Opioid Dependence
Feb 19, 2016Titan Pharmaceuticals Announces Notification of FDA Action Date Extension for Probuphine
Jan 12, 2016Titan Pharmaceuticals And Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval Of Probuphine
Sep 28, 2015Titan Pharmaceuticals Announces FDA's Acceptance of Resubmission of NDA for Probuphine
Jun  8, 2015Titan Pharmaceuticals Reports Positive Results from Phase 3 Study of Probuphine for Opioid Addiction
May  1, 2013Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application
Feb 27, 2013Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine for the Treatment of Opioid Dependence
Oct 29, 2012Titan Pharmaceuticals Announces Submission of New Drug Application for Probuphine for the Treatment of Opioid Dependence

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.