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# Put Conditions on Injectafer sNDAs: Petition
- URL: https://www.fdaweb.com/put-conditions-on-injectafer-sndas-petition/
- Published: 2022-02-10T12:00:00.000Z
- Updated: 2026-09-14T17:32:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151133

A 2/3 petition submitted by the Axinn law firm asks FDA to: 

- deny any Injectafer (ferric carboxymaltose injection) sNDAs for labeling changes based on the FAIR-HF and CONFIRM-HF trials, including any supportive data from AFFIRM-AHF, unless intended to add or strengthen a Contraindication, Warning, Precaution, or Adverse Reaction;
- strengthen Injectafer Warnings and Precautions and its dosage and administration concerning severe and symptomatic hypophosphatemia and its consequences; and
- require any potential future expanded or additional indication for Injectafer to be based on well-controlled clinical studies that specifically assess the risks of severe and symptomatic hypophosphatemia and its consequences for such intended use.

The [petition](https://downloads.regulations.gov/FDA-2022-P-0144-0001/attachment%5F1.pdf?ref=fdaweb.com) says FDA approved Injectafer 7/25/13\. American Regent is the current NDA holder, it says, and the drug is marketed globally by Vifor Pharma under the brand name Ferinject. Vifor also sponsored the three trials cited in the petition.

Injectafer is an iron replacement product currently indicated for treating iron deficiency anemia in adults and pediatric patients under specified conditions.

Axinn says the three trials “exhibit several significant deficiencies that should prevent FDA from being able to reach a favorable risk/benefit assessment of Injectafer safety and effectiveness for use in patients with iron deficiency and heart failure with reduced ejection fraction based on the studies.”

“Ultimately,” it says, “the actions requested in this petition are intended to mitigate the potential for significant patient harm that could result from an expanded, and even current, use of Injectafer without additional appropriate and well-controlled clinical investigations.”