Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has resubmitted the New Drug Application (NDA) for Brixadi 1 (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA).
LUND, Sweden, June 15, 2021 /PRNewswire/ -- Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has resubmitted the New Drug Application (NDA) for Brixadi1 (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA). The resubmission is in response to the Complete Response Letter (CRL) issued by the FDA to Braeburn on 1 December 2020 citing deficiencies identified during a pre-approval inspection of Braeburn’s third-party manufacturer in the US. A Prescription Drug User Fee Act (PDUFA) action date for Brixadi is expected from the FDA within 30 days. For more information Fredrik Joabsson, Chief Business Development Officer About Camurus 1Brixadi™ is the US trade name for Camurus’ product Buvidal®. The information was submitted for publication at 11 pm CET on 15 June 2021. CONTACT: This information was brought to you by Cision http://news.cision.com The following files are available for download:
View original content:http://www.prnewswire.com/news-releases/camurus-announces-braeburn-resubmits-new-drug-application-for-brixadi-in-the-us-301313174.html SOURCE Camurus AB | ||||
Company Codes: Bloomberg:CAMX@SS, ISIN:SE0007692850, RICS:CAMX.ST, Stockholm:CAMX |