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Probuphine Approval History

  • FDA approved: Yes (First approved May 26th, 2016)
  • Brand name: Probuphine
  • Generic name: buprenorphine
  • Dosage form: Implant
  • Company: Titan Pharmaceuticals, Inc.
  • Treatment for: Opiate Dependence

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

Development History and FDA Approval Process 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
Jul 21, 2014Titan Pharmaceuticals Announces First Patient Enrollment In Clinical Study Of Probuphine for Opioid Dependence
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
Oct 13, 2010Titan Pharmaceuticals Announces Journal of the American Medical Association Publication of Phase 3 Probuphine Data

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