20 July 2017 - Priority review of the NDA has been applied for which, if granted, would shorten the review process of CAM2038.
Braeburn Pharmaceuticals and Camurus today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. FDA for the approval of the companies’ weekly and monthly buprenorphine depots (CAM2038) to treat Opioid Use Disorder.
Braeburn has also applied for priority review which, if granted, could shorten the review process of CAM2038 following the FDA’s acceptance of the NDA.