> ## 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.

# Spinraza Gets Regulatory Review Determination
- URL: https://www.fdaweb.com/spinraza-gets-regulatory-review-determination/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150494

*Federal Register* notice: FDA has determined for patent restoration purposes the regulatory review period for Biogen’s Spinraza (nusinersen sodium), indicated for treating spinal muscular atrophy in pediatric and adult patients. The review period is 1,891 days, which includes 1,799 days that occurred during the testing phase and 92 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-01/pdf/2021-23719.pdf?ref=fdaweb.com).