Posted by Michael Wonder on 28 Jun 2018
AcelRx receives European Commission approval for Dzuveo
27 June 2018 - AcelRx's Dzuveo receives EU approval for management of acute moderate to severe pain in medically monitored settings.
AcelRx Pharmaceuticals today announced that the European Commission has approved Dzuveo (under development in the U.S. as Dsuvia) for the management of acute moderate to severe pain in adults in medically monitored settings.
Dzuveo represents the second EC approval for an AcelRx developed product, with the first being Zalviso, which is currently being marketed in Europe by Grünenthal.
AcelRx previously announced the acceptance of the resubmitted new drug application for Dsuvia (approved in Europe as Dzuveo) by the U.S. FDA, for which the FDA has assigned a PDUFA goal date of 3 November 2018.
