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U.S. Centers for Disease Control and Prevention
• U.S. News
FDA Approves Bristol-Myers's New Hepatitis Drug
March 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.
Excerpted from:Back to other news for March 30, 2005 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. |
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