PLYMOUTH MEETING, PA — Braeburn announced that this week 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.
Braeburn has worked closely with the third-party manufacturer to address the deficiencies identified in the CRL. The CRL did not cite any other deficiencies other than those related to third-party manufacturing. Braeburn expects to receive a PDUFA date in 30 days.
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