> ## 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.

# Pfizer’s Vyndagel Regulatory Review Period
- URL: https://www.fdaweb.com/pfizers-vyndagel-regulatory-review-period/
- Published: 2024-10-21T12:00:00.000Z
- Updated: 2026-09-14T14:44:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158019

*Federal Register* notice: FDA has determined for patent term extension purposes the regulatory review period for Pfizer’s Vyndaqel (tafamidis meglumine), indicated for treating cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. The regulatory review period is 4,978 days, of which 4,794 days occurred during the testing phase and 184 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-10-21/pdf/2024-24188.pdf?ref=fdaweb.com).