Braeburn initiates court proceedings to overturn exclusivity and seeks immediate market approval of Brixadi™ in the US
Lund, Sweden — 9 April 2019 — Camurus’ (NASDAQ STO: CAMX) US partner, Braeburn Inc., today announced that the company today will file an action in federal district court for the District of Columbia, seeking to overturn the 3-year market exclusivity granted by the US Food and Drug Administration (FDA) to Sublocade™, and seeking immediate approval of Brixadi™ (buprenorphine) extended-release solution (the US trade name for Camurus’ product Buvidal®). The court action, which will include a motion for preliminary injunction, is based on thorough legal and regulatory assessments and is made