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# Regulatory Review Period Determined for Vraylar
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-vraylar/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140609

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. Of this time, 2,709 days occurred during the testing phase and 1,033 days occurred during the approval phase. Vraylar is indicated for treating schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-26/pdf/2018-01368.pdf?ref=fdaweb.com).