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PRINCETON, N.J. -- Bristol-Myers Squibb Company today announced the submission of a New Drug Application to the Food and Drug Administration (FDA) for entecavir, an investigational antiviral agent under development for the treatment of chronic hepatitis B.
In the European Union, the company also submitted a marketing authorization application for entecavir to the European Medicines Evaluation Agency.
Entecavir is an investigational oral antiviral discovered at Bristol-Myers Squibb that is designed to selectively inhibit the Hepatitis B virus, blocking all three steps in the replication process.
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
Source: Bristol-Myers Squibb Company