For Patients

Timeline / History

2014 - Present 

To view the most up-to-date information on HIV/AIDS approvals, visit "What's New at FDA in HIV/AIDS".

2010 - 2013

2011 marks the beginning of the third decade of HIV/AIDS. The first reports of Pnemocystis Pneumonia in young men were published on June 5, 1981 in the CDC's Morbidity and Mortality Weekly Report (MMWR). 2011 saw new diagnostic assays that could further shorten the window period and help detect new infections, drug approvals that added more options to treatment regimens, generic drug approvals that can help lower the cost of treatment, and several labeling changes to improve management of safety in treating HIV.


In the first years of the century, new formulations and combinations of medications were approved to reduce pill burden. HIV genotyping was approved to help improve treatment outcome. The first nucleic acid test for plasma screening, the first rapid HIV test for use in outreach settings, the first fusion inhibitor for treatment of HIV/AIDS, and the first generic version of an HIV therapeutic agent were also approved.


The final years of the century saw approval of the first protease inhibitor, a new class of drugs for treating HIV, the first home-use AIDS test kit, the first antigen test kit to screen blood donors for HIV-1, and the first viral load test ...


These years saw the creation of the National Task Force on AIDS Drug Development, large scale expanded access to pre-approved HIV therapies, and approval of a number of new drugs. Accelerated approval permitted earlier approval of therapies based on surrogate marker activity. The first non blood-based collection system was approved to test for HIV, and the female condom was approved, providing women with a barrier product that didn't rely on a woman's partner to use...


This decade saw the first report of AIDS and its identification as a retrovirus, approval of the first immunoassay test, and approval of AZT, the first drug to treat AIDS, and the first drugs for treatment and prevention of certain opportunistic infections, and a mechanism for expanded access to promising therapies prior to approval...


Page Last Updated: 04/11/2016
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