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# Regulatory Review Period for Novo Nordisk’s Tresiba
- URL: https://www.fdaweb.com/regulatory-review-period-for-novo-nordisks-tresiba/
- Published: 2016-12-02T12:00:00.000Z
- Updated: 2026-09-14T21:52:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137474

*Federal Register* Notice: FDA has determined the regulatory review period for Novo Nordisk’s diabetes therapy Tresiba (insulin degludec injection) for patent extension purposes is 2,914 days. Of this time, 1,456 days occurred during the testing phase, while 1,458 days occurred during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-02/pdf/2016-28939.pdf?ref=fdaweb.com).