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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: Gilead Refiles for Approval of HIV Drug


San Francisco Business Times (02.10.2011) - Friday, February

Foster City, Calif.-based Gilead Sciences Inc. has resubmitted its application seeking Food and Drug Administration-approval of a three-in-one HIV drug. The combination includes Gilead's Truvada (emtricitabine and tenofovir) with TMC-278, an investigational drug made by Tibotec Pharmaceuticals, a unit of Johnson & Johnson. TMC-278 is a non-nucleoside reverse transcriptase inhibitor. In January, FDA said it wanted more information about TMC-278. With the refiling, FDA now has up to 60 days to perform a preliminary review of the drug cocktail and establish a target date for action.


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Information in this article was accurate in February 11, 2011. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.