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# Regulatory Review Period for Omegaven
- URL: https://www.fdaweb.com/regulatory-review-period-for-omegaven/
- Published: 2023-10-31T12:00:00.000Z
- Updated: 2026-09-14T14:14:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155687

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for [Fresenius Kabi’s ](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjX047KxqCCAxV2l4kEHd7YC9wQFnoECBwQAQ&url=https%3A%2F%2Ffreseniuskabinutrition.com%2Fproducts%2Fomegaven%2F&usg=AOvVaw3moDhavg9-J1A-r9%5FTqO9M&opi=89978449)Omegaven (fish oil triglycerides) indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis. The regulatory review period for Omegaven is 4,246 days, of which 4,007 days occurred during the testing phase and 239 days occurred during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-24124.pdf?ref=fdaweb.com).