Camurus announces PDUFA date for CAM2038 for the treatment of opioid use disorder
Lund, Sweden – 16 July 2018 — Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 for its investigational weekly and monthly buprenorphine depots, CAM2038, for the treatment of adults with opioid use disorder (OUD). The FDA considers the resubmission of the New Drug Application (NDA) by Camurus’ US partner Braeburn a complete response to the January 19, 2018, action letter. “We are pleased that the FDA has assigned a target action date for a US approval decision for