Camurus announces PDUFA date for Brixadi™ NDA for the treatment of opioid use disorder in the US
Prescription Drug User Fee Act (PDUFA) action date set for 23 May 2023 Lund, Sweden — 8 December 2022 — Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Brixadi* (buprenorphine) extended-release injection for subcutaneous (SC) use (Schedule III Controlled Substance) for the treatment of moderate to severe opioid use disorder. The NDA was resubmitted to the Agency by Camurus’ licensee Braeburn on 23 November 2022. The new Prescription Drug User Fee Act (PDUFA) action date is set for 23 May