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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 drugs
July 28, 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 FDA.
Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US firstwordpharma
June 28, 2021
Camurus announced today that the NDA by Camurus' US licensee Braeburn for Brixadi™ (buprenorphine) extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted for review by the FDA.
Braeburn Submits Request for Final Approval of BRIXADI for Opioid Use Disorder americanpharmaceuticalreview
June 11, 2020
Braeburn 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).
Braeburn Announces Tentative FDA Approval of BRIXADI americanpharmaceuticalreview
December 27, 2018
Braeburn announced the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and ......