U.S. District Court Orders FDA to Reconsider Application for Final Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

The U.S. District Court for the District of Columbia (District Court) granted Braeburn’s motion for summary judgment, vacating the U.S. Food and Drug Administration’s (FDA) December 2018 exclusivity determination which blocked Brixadi from final approval through November 30, 2020. Braeburn’s application for final approval of Brixadi is remanded back to FDA for reconsideration “with deliberate speed.”

Source: Braeburn

Read more at: https://braeburnrx.com/u-s-district-court-orders-fda-to-reconsider-braeburns-application-for-final-approval/