Probuphine Approval History
FDA Approved: Yes (First approved May 26, 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, 2016|| FDA Approves Probuphine (buprenorphine) Implant for Treatment of Opioid Dependence|
|Feb 19, 2016||Titan Pharmaceuticals Announces Notification of FDA Action Date Extension for Probuphine|
|Jan 12, 2016||Titan Pharmaceuticals And Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval Of Probuphine |
|Sep 28, 2015||Titan Pharmaceuticals Announces FDA's Acceptance of Resubmission of NDA for Probuphine|
|Jun 8, 2015||Titan Pharmaceuticals Reports Positive Results from Phase 3 Study of Probuphine for Opioid Addiction|
|Jul 21, 2014||Titan Pharmaceuticals Announces First Patient Enrollment In Clinical Study Of Probuphine for Opioid Dependence |
|May 1, 2013||Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application|
|Feb 27, 2013||Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine for the Treatment of Opioid Dependence|
|Oct 29, 2012||Titan Pharmaceuticals Announces Submission of New Drug Application for Probuphine for the Treatment of Opioid Dependence|
|Oct 13, 2010||Titan Pharmaceuticals Announces Journal of the American Medical Association Publication of Phase 3 Probuphine Data|
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