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FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Prescription Drug User Fee Act (PDUFA) action date set for December 15, 2021. Plymouth Meeting, Pa. – June 26, 2021 – Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food…
Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa. – June 15, 2021 – Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resubmitted to the U.S. Food and Drug Administration (FDA). The resubmission is in response to a Complete Response Letter issued…
Braeburn Announces Arbitration Determination that It Did Not Materially Breach Its License Agreement with Camurus AB
Plymouth Meeting, Pa. – December 10, 2020 – Braeburn announces that a tribunal appointed by the ICC International Court of Arbitration decided that Braeburn did not materially breach its license agreement with Camurus for the development and commercialization of an extended-release buprenorphine subcutaneous injection product. As a result of this decision, Braeburn retains all North…
Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa. — December 2, 2020 — Braeburn announces that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for the treatment of moderate to severe opioid use disorder. In the CRL, the…
Braeburn Appoints Brian Hirsch as General Counsel
Plymouth Meeting, Pa. —September 15, 2020—Braeburn announces that it has appointed Brian Hirsch as General Counsel and Corporate Secretary. Mr. Hirsch joins Braeburn with more than 20 years of pharmaceutical and legal experience, handling complex legal matters for both branded and generic biopharmaceutical companies. He most recently served as Senior Vice President, Global IP, and…
Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder
Plymouth Meeting, Pa. —June 1, 2020 — Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of opioid use disorder (OUD). Once approved, BRIXADI will be the only long-acting injectable buprenorphine that…