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# FDA Determines Regulatory Review Period for Rukobia
- URL: https://www.fdaweb.com/fda-determines-regulatory-review-period-for-rukobia/
- Published: 2022-06-29T12:00:00.000Z
- Updated: 2026-09-14T17:50:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152194

*Federal Register* notice: FDA has determined for patent restoration purposes the regulatory review period for ViiV Healthcare’s Rukobia (fostemsavir tromethamine), indicated in combination with other antiretrovirals for treating HIV–1 infection in heavily treatment-experienced adults. The review period is 5,322 days, of which 5,110 days occurred during the testing phase and 212 days occurred during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-29/pdf/2022-13856.pdf?ref=fdaweb.com).