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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…
FDA Grants Braeburn’s Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
FDA revokes Indivior PLC’s orphan designation for opioid use disorder (OUD)* and prevents an additional five-year block of other monthly buprenorphine depot products for OUD Plymouth Meeting, Pa. – November 7, 2019 – Braeburn Inc. is pleased to confirm that it will seek, and is eligible for, marketing approval for BRIXADI™ (buprenorphine) weekly and monthly…