Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US

Camurus

26 June 2021 - New PDUFA action date for Brixadi set for 15 December 2021.

Camurus announced today that the new drug application by Camurus' US licensee Braeburn for Brixadi (buprenorphine) extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted for review by the US FDA.

Read Camurus press release

Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Dossier