PLYMOUTH MEETING, Pa., Dec. 8, 2022 /PRNewswire/ -- 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). The PDUFA action date is set for May 23, 2023.
FDA Accepts Braeburn`s New Drug Application Resubmission for BRIXADi
PLYMOUTH MEETING, Pa., June 15, 2021 /PRNewswire/ -- 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 by the FDA in December citing deficiencies found during an inspection at a third-party manufacturing facility.