• 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
2 KOLs are featured in this series.
2 KOLs are featured in this series.
Can 18F-Floutufolastat Bolster Detection of PCa Recurrence in Patients with Low PSA Levels After Radical Prostatectomy?
2 KOLs are featured in this series.
2 KOLs are featured in this series.
2 KOLs are featured in this series.
2 KOLs are featured in this series.
2 KOLs are featured in this series.
2 KOLs are featured in this series.
2 KOLs are featured in this series.
Related Content
© 2024 MJH Life Sciences

All rights reserved.