European Commission approves Dzuveo to manage acute moderate to severe pain in medically monitored settings.- AcelRx Pharmaceuticals Inc.
AcelRx Pharmaceuticals, Inc. announced that the European Commission (EC) 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 Gr�nenthal.
AcelRx previously announced the acceptance of the resubmitted New Drug Application for Dsuvia (approved in Europe as Dzuveo by the FDA for which the FDA has assigned a PDUFA (Prescription Drug User Fee Act) date of November 3, 2018.
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