TITLE

FDA Panel Recommends Approval of Quad Regimen

AUTHOR(S)
Shaffer, Catherine
PUB. DATE
May 2012
SOURCE
BioWorld Today;5/14/2012, Vol. 23 Issue 93, p1
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the vote by the U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee (AVAC) in favor of approval for Gilead Inc.'s single-tablet Quad regimen for treatment-naive adult patients with HIV-1. The safety data of the Quad regimen was closely examined by the committee, specifically with respect to renal function. The Quad regimen is composed of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
ACCESSION #
75359980

 

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