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.
www.aegis.org