> ## 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 Puma’s Nerlynx
- URL: https://www.fdaweb.com/regulatory-review-period-for-pumas-nerlynx/
- Published: 2019-08-30T12:00:00.000Z
- Updated: 2026-09-15T01:47:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144898

*Federal Register* notice: FDA has determined the regulatory review period for patent extension purposes for Puma Bio’s Nerlynx (neratinib), indicated for extended adjuvant treatment of adult patients with early stage HER2- overexpressed/amplified breast cancer. The review period was 5,102 days, which includes 4,738 days that occurred during the testing phase and 364 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-30/pdf/2019-18816.pdf?ref=fdaweb.com).