> ## 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 Synergy’s Trulance
- URL: https://www.fdaweb.com/regulatory-review-period-for-synergys-trulance/
- Published: 2018-12-04T12:00:00.000Z
- Updated: 2026-09-15T00:48:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142951

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Synergy Pharmaceuticals’ Trulance (plecanatide), indicated in adults for treating chronic idiopathic constipation. The regulatory review period has been determined to be 3,186 days, which included 2,829 days that occurred during the testing phase and 357 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-04/pdf/2018-26289.pdf?ref=fdaweb.com).