Print this page    •   Back to Web version of article

U.S. News
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.

Back to other news for February 2011

Excerpted from:
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. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/art60479.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.