Article Excerpt: Camurus announced that the Food and Drug Administration (FDA) has deemed the resubmission of the New Drug Application (NDA) of CAM2038 (buprenorphine) by Braeburn as a complete response to the January 19, 2018 action letter. As a result, a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 has been assigned for the investigational weekly and monthly depots of buprenorphine for the treatment of adults with opioid use disorder (OUD).
Full Article: https://tinyurl.com/y9p6woa9
Article Source: Monthly Prescribing Reference (MPR)