Posted by Michael Wonder on 16 Dec 2021
Braeburn receives new complete response letter for Brixadi in the US
15 November 2021 - Camurus today announced that its US licensee Braeburn has received a complete response letter from the US FDA for its updated new drug application for Brixadi (buprenorphine) extended-release injections for the treatment of opioid use disorder.
The complete response letter is a result of continued quality related deficiencies at Braeburn's US based third party manufacturer, identified by the FDA during a pre-approval inspection.
