AMAG Pharmaceuticals, Inc. Receives Fast Track Designation for Ferumoxytol for Vascular-Enhanced Magnetic Resonance Imaging

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ferumoxytol for its development as a diagnostic agent for Vascular-Enhanced Magnetic Resonance Imaging (VE-MRI) to improve the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease (CKD). If approved for an imaging indication, ferumoxytol could offer an alternative to gadolinium-based contrast agents, which are required to contain a black box warning highlighting the risks of using gadolinium-based agents in patients with advanced kidney disease.

MORE ON THIS TOPIC