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NEW COMPOUNDS: FDA Panel Supports Hep B Approval.(Food and Drug Administration approves Gilead Sciences agent for chronic hepatitis B treatment)(Brief Article)

Drug Discovery & Technology News

| August 01, 2002 | COPYRIGHT 2000 BCC Research. (Hide copyright information)Copyright

U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously voted in support of approval of the Gilead Science's (333 Lakeside Dr., Foster City, CA 94404; Tel: 650/574- 3000, Fax: 650/578-9264) investigational antiviral agent, adefovir dipivoxil 10 mg, for the treatment of chronic hepatitis B. The FDA will consider the Advisory Committee's recommendations as it completes its priority review of the adefovir dipivoxil New Drug Application (NDA), submitted on March 21, 2002. If approved, adefovir dipivoxil will be the first commercially available nucleotide analogue for use in the treatment of chronic hepatitis B and the first new treatment approved …

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