Camurus announces FDA acceptance of NDA submission for Oclaiz™ for treatment of acromegaly
Prescription Drug User Fee Act date (PDUFA) set to 21 October 2024 Lund, Sweden — 5 March 2024 — Camurus (NASDAQ STO: CAMX) today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for Oclaiz[TM] (CAM2029) for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 21 October 2024. CAM2029 is a novel, octreotide subcutaneous depot designed for convenient, once-monthly self-administration, enhanced octreotide plasma exposure, and robust disease