Braeburn announces that the New Drug Application (NDA) for Brixadi (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) action date is set for December 15, 2021.
“We are pleased that the FDA has accepted our application for Brixadi,” said Mike Derkacz, President and CEO of Braeburn. “We look forward to working with the FDA to advance Brixadi toward approval and to providing another option for healthcare providers to treat their patients with opioid use disorder, a disease that continues to have a devastating impact on patients, their loved ones, and communities.”
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