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Braeburn Applauds Passage of Significant Advancements in the Treatment of Opioid Use Disorder
Plymouth Meeting, Pa.—December 23, 2022—The recently passed Senate Amendment to H.R. 2617 – Consolidated Appropriations Act, 2023 – includes significant advances in the treatment of opioid use disorder by expanding access to treatment and eliminating policies that created barriers and contributed to stigmatization of the disease. “The passage of H.R. 2617 reinforces the depth and…
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 May 23, 2023. Plymouth Meeting, Pa.—December 8, 2022—Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injections for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration (FDA)….
Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa.—November 23, 2022—Braeburn announces that the company has resubmitted to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder. The resubmission is in response to a Complete Response Letter issued by the FDA…
Braeburn Appoints Joshua M. Cohen, MD, MPH, FAHS as Chief Medical Officer
Plymouth Meeting, Pa.—September 24, 2021—Braeburn announces that Joshua M. Cohen, MD, MPH, FAHS has joined the company as Chief Medical Officer. Dr. Cohen will play a critical role within Braeburn’s leadership team overseeing the medical affairs and research and development functions as the Company continues to grow. Dr. Cohen brings extensive experience in pharmaceutical and…
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…