> ## 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 Welireg
- URL: https://www.fdaweb.com/regulatory-review-determined-for-welireg/
- Published: 2023-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:18:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155967

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Peloton Therapeutics Welireg (belzutifan), indicated for treating adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors. The regulatory review period is 1,752 days, of which 1,541 days occurred during the testing phase and 211 during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-11/pdf/2023-27044.pdf?ref=fdaweb.com).