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# Regulatory Review for Gilead’s Genvoya
- URL: https://www.fdaweb.com/regulatory-review-for-gileads-genvoya/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140702

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Gilead Sciences’ Genvoya (cobicistat, emtricitabine, elvitegravir, and tenofovir alafenamide fumarate) is 5,031 days. Of this time, 4,665 days occurred during the testing phase and 366 days during the approval phase. Genvoya is indicated for treating HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-07/pdf/2018-02403.pdf?ref=fdaweb.com).