Camurus announces positive outcome of US court proceeding about final approval of Brixadi™
FDA ordered to reconsider, with deliberate speed, Braeburn’s application for final approval of Brixadi™ Lund, Sweden — 23 July 2019 — Camurus AB (NASDAQ STO: CAMX) today announces that the United States District Court for the District of Columbia grants Braeburn’s motion for summary judgement, vacating the U.S. Food and Drug Administration’s (FDA) decision to block final market approval of Brixadi™ Monthly. The court rules that, in December 2018, the FDA acted inconsistently with precedent by delaying the approval of Brixadi™ and granting a three-year exclusivity to Sublocade™. The case