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# Regulatory Review For AstraZeneca’s Farxiga
- URL: https://www.fdaweb.com/regulatory-review-for-astrazenecas-farxiga/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140701

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for AstraZeneca’s Farxiga (dapagliflozin) is 3,673 days. Of this time, 2,565 days occurred during the testing phase and 1,108 days during the approval phase. Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-07/pdf/2018-02418.pdf?ref=fdaweb.com).