15 June 2021 - Braeburn announces that today the new drug application for Brixadi (buprenorphine) extended release injection for subcutaneous use for moderate to severe opioid use disorder was resubmitted to the U.S. FDA. 

The resubmission is in response to a complete response letter issued by the FDA in December citing deficiencies found during an inspection at a third party manufacturing facility.

Braeburn has worked closely with the third party manufacturer to address the deficiencies identified in the complete response letter. The letter did not cite any other deficiencies other than those related to third-party manufacturing. 

Braeburn expects to receive a PDUFA date in 30 days.

Read Braeburn Pharmaceuticals press release