> ## 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.

# Reg Review Determination on Celegene’s Cerdelga
- URL: https://www.fdaweb.com/reg-review-determination-on-celegenes-cerdelga/
- Published: 2016-11-22T12:00:00.000Z
- Updated: 2026-09-14T21:49:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137411

*Federal Register* Notice: FDA has determined the regulatory review period for Celgene’s Cerdelga (eliglustat) for patent extension purposes — 3,854 days. Of this time, 3,520 days occurred during the testing phase of the regulatory review period, while 334 days occurred during the approval phase.