Positive outcome for Camurus in court proceedings regarding final approval of Brixadi™ in the US
Camurus’ partner Braeburn have received a positive outcome in the US court proceedings which were initiated in April, 2019, regarding final approval for Brixadi (Buvidal® in the US) and the FDA is remanded to reconsider Braeburn’s application for final approval of Brixadi™ Monthly in the US.
The United States District Court for the District of Columbia grants Braeburn’s motion for summary judgement, vacating the FDA's decision to block final market approval of Brixadi™Monthly. According to the court ruling, the FDA is remanded to speedily reconsider Braeburn’s application for final approval of Brixadi™ Monthly in the US. Buvidal is approved for the treatment of opioid dependence in the EU and Australia.