> ## 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 Determined for Orion’s Nubeqa
- URL: https://www.fdaweb.com/regulatory-review-determined-for-orions-nubeqa/
- Published: 2021-10-21T12:00:00.000Z
- Updated: 2026-09-14T17:19:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150411

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Orion Corp.’s Nubeqa (darolutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,576 days, which includes 2,420 days that occurred during the testing phase and 156 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-23074.pdf?ref=fdaweb.com).