On August 27, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of Stribild, a drug intended to treat the HIV-1 infection in adult individuals who have not previously received treatment for the infection. Manufactured by Gilead Sciences, Stribild is a combination pill containing four separate drugs, two previously approved for the treatment of HIV (elvitegravir and cobicistat) and two new drugs (emtricitabine and tenofovir disoproxil fumarate). The FDA approved pill is a significant step in the treatment of HIV in that it illustrates the evolution and simplification of treatment options for the infection, which was formerly treated with onerous multi-pill regimen.
The FDA’s approval of Stribild is just one of several regulatory decisions helping to advance the detection and treatment of HIV this year. In particular, the FDA approved the first over-the-counter at-home HIV test kit in July 2012. Our previous report detailing the approval of this device may be accessed here. For more information about the FDA approval process or the laws and regulations enforced by the FDA generally, please contact us at contact@sglawfl.com.
