• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

FDA refuses Advanced Magnetics

Article

Advanced Magnetics’ bid to expand the labeling of MRI liver contrast agent Feridex I.V. has failed. The FDA has declared the company’s supplemental new drug application “not approvable.” Advanced Magnetics had hoped to increase

Advanced Magnetics’ bid to expand the labeling of MRI liver contrast agent Feridex I.V. has failed. The FDA has declared the company’s supplemental new drug application “not approvable.” Advanced Magnetics had hoped to increase the appeal of Feridex, which has floundered in the marketplace, by including differentiation of liver lesions as benign or metastatic and changing the dosing regimen to allow more rapid infusion. The agent, which was originally approved by the FDA on Aug. 30, 1996, is marketed in the U.S. by Berlex Laboratories, a subsidiary of Schering of Germany.

Recent Videos
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 3
Related Content
© 2025 MJH Life Sciences

All rights reserved.