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World AIDS Day

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Cross-posted from the FDA Blog World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically…

FDA approves first drug for reducing the risk of sexually acquired HIV infection

blog.aids.gov

Today (July 16, 2012), the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for…

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

FDA

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),…

FDA and FTC Act to Remove Fraudulent HIV and STD Products from the Market

STDTreatments

Last month the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases (STDs), including HIV/AIDS. Among the products targeted in the action are Medavir, Herpaflor, Viruxo, C-Cure, and Never An…

FDA Approves Second New Treatment for Hepatitis C

blog.aids.gov

On May 23, the U.S. Food and Drug Administration (FDA) announced the approval of telaprevir for the treatment of chronic viral hepatitis C. According to the U.S. Centers for Disease Control and Prevention, chronic viral hepatitis C affects 3.2 million Americans. Left untreated, chronic viral hepatitis C can lead to cirrhosis, liver cancer, and unwitting…

FDA Approves New Rapid HIV Test Delivering Results in 60 Seconds

Richard Klein

Earlier this week the Food and Drug Administration (FDA) announced the approval of the INSTI™ HIV-1 Antibody Test, a new, single use rapid test for the detection of HIV antibodies developed by bioLytical Laboratories of Canada. The newly approved test provides results in as little as 60 seconds, in contrast to the six previously approved…

FDA Advises Patients and Care Providers on Drug Combination Safety Considerations

FDA

The U.S. Food and Drug Administration (FDA) is committed to keeping the public updated on advances and shifts in treatment options and methods. The FDA is reviewing data that suggest use of the HIV drug Invirase (saquinavir) in combination with Norvir (ritonavir) may have a potentially serious effect on a patient’s heart. The data, drawn…