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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES: Gilead Refiles for Approval of HIV Drug
Ron Leuty
February 11, 2011
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.