> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Iron-Based MRI Contrast Agent
- URL: https://www.fdaweb.com/fda-oks-iron-based-mri-contrast-agent/
- Published: 2025-10-17T12:00:00.000Z
- Updated: 2026-09-14T15:24:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160061

FDA has approved Azurity Pharmaceuticals’ Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant brain tumors. The product is designed to help radiologists visualize lesions with a disrupted blood-brain barrier, enhancing the detection and delineation of both primary and metastatic brain neoplasms, according to the company.

Azurity says approval is based on data from a pivotal clinical study, which showed that a Ferabright-enhanced MRI significantly improved visualization of brain tumors compared with pre-contrast imaging. The drug’s extended imaging window, resulting from its long half-life, may allow for more flexible MRI scheduling and potentially reduce the need for repeat contrast administration, the company says.

Because Ferabright is iron-based, it is processed through the body’s natural iron metabolism pathways — potentially minimizing the long-term tissue retention risks associated with gadolinium-based agents, the company says. The drug is also suitable for patients with renal insufficiency, providing an option for those who cannot safely receive other MRI contrast materials.