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U.S. News FDA Approves Bristol-Myers's New Hepatitis DrugMarch 30, 2005 On Tuesday, the Food and Drug Administration approved Bristol-Myers's Baraclude (entecavir), an oral drug for treatment of chronic hepatitis B. An FDA advisory panel, which unanimously endorsed the approval, found a potential risk of tumors was not significant enough to outweigh Baraclude's benefits. The drug was put on fast track review after regulators found it addressed a serious unmet need. New York Times 03.30.05; Stephanie Saul This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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