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# Review Period for Biomarin’s Palynziq
- URL: https://www.fdaweb.com/review-period-for-biomarins-palynziq/
- Published: 2019-12-06T12:00:00.000Z
- Updated: 2026-09-14T15:55:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145670

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz), indicated to reduce blood phenylalanine concentrations in certain adult patients with phenylketonuria. The regulatory review period is 3,803 days, which includes 3,474 days that occurred during the testing phase and 329 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-12-06/pdf/2019-26327.pdf?ref=fdaweb.com).