Gilead Refiles for Approval of HIV Drug
February 11, 2011
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.
San Francisco Business Times
02.10.2011; Ron Leuty
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
Add Your Comment:
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)