> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Regulatory Review Period for Ardea Bio’s Zurampic
- URL: https://www.fdaweb.com/regulatory-review-period-for-ardea-bios-zurampic/
- Published: 2018-01-22T12:00:00.000Z
- Updated: 2026-09-14T23:15:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140564

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Ardea Biosciences’ Zurampic (lesinurad) was 2,245 days. Of this time, 1,886 days occurred during the testing phase and 359 days occurred during the approval phase. The product is indicated in combination with a xanthine oxidase inhibitor for treating hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/pdf/2018-00992.pdf?ref=fdaweb.com).