Posted by Michael Wonder on 26 Mar 2018
Health Canada accepts Cardiome's Xydalba new drug submission and grants priority review
22 March 2018 - Approval decision expected in third quarter 2018.
Cardiome Pharma Corporation announced today that Health Canada has accepted its new drug submission for review of Xydalba (dalbavancin hydrochloride) and granted priority review status to the application. Cardiome expects to receive an approval decision for Xydalba during the third quarter of 2018.
Under the proposed strategic transaction between Cardiome and Cipher Pharmaceuticals, Cipher would sublicense the commercial rights to Xydalba as part of the Canadian business portfolio proposed for acquisition.
Standard review in Canada takes 300 days and priority review, which is granted to promising medicines that address life-threatening or severely debilitating conditions, shortens the review time to approximately 180 days.
