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# FDA Denies Fresenius Keryx Petition
- URL: https://www.fdaweb.com/fda-denies-fresenius-keryx-petition/
- Published: 2017-11-08T12:00:00.000Z
- Updated: 2026-09-14T23:00:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140078

FDA has denied a Vifor Fresenius Medical Care Renal Pharma 7/12 petition asking that FDA not approve a pending sNDA for Auryxia (ferric citrate) submitted by Keryx Pharmaceuticals. The petition asked that FDA only consider the proposed iron deficiency anemia (IDA) indication after Keryx submits an additional NDA containing clinical studies that **(1)** adequately demonstrate the long-term safety of the drug for the IDA indication and **(2)** adequately demonstrate that the drug can be safely labeled and dosed for IDA in non-dialysis-dependent chronic kidney disease (NDD-CKD).

The [denial](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-4334-0042&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) letter says the agency “has determined that there is sufficient data to support its finding that Auryxia is safe and effective for both of its labeled indications: treatment of iron deficiency anemia in NDD-CKD and treatment of hyperphosphatemia in DD-CKD. Regardless of whether a request for approval of an indication is submitted in a supplement or in a standalone NDA, the standard for approval is the same: the drug must be safe and effective when used for the proposed indication. Thus, we decline to grant your request that we refuse to approve the sNDA and only consider the IDA indication as part of a new NDA for ferric citrate.”