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:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)