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# FDA Denies Akebia Reconsideration Petition
- URL: https://www.fdaweb.com/fda-denies-akebia-reconsideration-petition/
- Published: 2025-12-17T12:00:00.000Z
- Updated: 2026-09-14T15:29:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160403

FDA has denied a 2/19/2019 petition for reconsideration submitted by Akebia Therapeutics asking the agency to reconsider its decision denying five-year new chemical entity exclusivity to the company’s Auryxia (ferric citrate) oral tablets. In its denial [letter](https://downloads.regulations.gov/FDA-2018-P-3284-0025/attachment%5F2.pdf?ref=fdaweb.com), FDA says it denied the company’s original request for exclusivity on 1/19/2019 after finding that Auryxia is not a drug that contains no active moiety that has been approved by FDA in any other application.

In response to the company’s petition for reconsideration, FDA says the company “has not demonstrated that relevant information and views in the administrative record were not adequately considered when we denied the petition…. We also conclude that Akebia has not demonstrated sound public policy grounds supporting reconsideration…. Because a petition for reconsideration must be granted only if each of the requirements \[listed in the regulations\] are met, we are not required to grant the reconsideration petition. Furthermore, we do not find that granting the reconsideration petition would be in the public interest or in the interest of justice.”