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A PDUFA target date of December 15, 2021 has been set for the application. (Credit: Getty Images.) The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brixadi™ (buprenorphine) extended-release weekly and monthly subcutaneous injection for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. The resubmitted NDA was in response to a Complete Response Letter (CRL) issued by the FDA in December 2020. In the CRL, the FDA stated that the NDA could not be approved in its present form due to “deficiencies found during a recent inspection at a third-party manufacturing facility in the US.” No other deficiencies were noted in the application, which included data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT02651584) that compared

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