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Thursday, 19 April 2012 07:49

FDA Advisory Committees to Examine a Number of HIV Issues in May

18 April 2012 (AIDS.Gov) - The U.S. Food and Drug Administration (FDA) has three important advisory committee meetings scheduled in May that may impact HIV prevention, detection, and treatment.

On May 10, 2012, FDA’s Antiviral Advisory Committee will discuss expanding the indication of Truvada (emtricitabine/tenofovir disoproxil fumarate) tablet, made by Gilead Sciences, Inc., to include use for Pre-Exposure Prophylaxis (PrEP), to reduce the risk of sexually acquired HIV–1 infection.  Truvada is currently approved for treatment of HIV infection.  Read more on this page.

On May 11, 2012, the Antiviral Drugs Advisory Committee will discuss a new drug application (NDA) 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 naive or have no known genetic substitutions associated with resistance to the individual drug components. More details available on this page.

Finally, on May 15, 2012, the FDA Blood Products Advisory Committee will meet to discuss the evaluation of data related to the safety and effectiveness of the OraQuick In-Home HIV Test. This is the first application for FDA approval of a home-use rapid test for detection of infection with HIV. Details about this meeting are found on this page.

The public is invited to comment on these topics and to attend FDA advisory committee meetings; see the links above for details about each meeting.


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