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# FDA Approves Amag Pharma Expanded Label for Feraheme
- URL: https://www.fdaweb.com/fda-approves-amag-pharma-expanded-label-for-feraheme/
- Published: 2018-02-05T12:00:00.000Z
- Updated: 2026-09-14T23:19:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140685

FDA has approved an Amag Pharmaceuticals supplemental NDA to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication to include all eligible adult iron deficiency anemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Approval was based on data from two pivotal Phase 3 trials evaluating Feraheme versus iron sucrose or placebo in a broad population of patients with iron deficiency anemia. It also included data from a clinical safety trial comparing Feraheme to Injectafer (ferric carboxymaltose injection) in 2,000 adults. The study demonstrated “comparability to Injectafer based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension,” the company says.