Antiviral Drugs Advisory Committee
Committee Meeting on May 11, 2012, from 8 a.m. to 5 p.m.
Agenda: The committee will discuss new drug application (NDA) 203-100, for a fixed dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components
Thursday, March 29, 2012
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