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Alkermes Seeks European OK for Vivitrol


Posted on 2007-04-02 10:23:00



Biotechnology company Alkermes Inc. said Monday it asked U.K. and German regulators to approve its extended-release Vivitrol to treat alcohol dependence.

The submission is under a decentralized process where the U.K. will act as a reference member state and Germany as the concerned member state for the application. If it is approved in one nation, it will receive simultaneous approval in the other.

The drug received U.S. Food and Drug Administration approval in April 2006.