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

Advanced Magnetics submits NDA for Combidex

Article

Contrast agent supplier Advanced Magnetics has submitted a new drug application (NDA) to the Food and Drug Administration for Combidex, an MRI contrast agent. The company’s European marketing partner, Guerbet, has also submitted the European

Contrast agent supplier Advanced Magnetics has submitted a new drug application (NDA) to the Food and Drug Administration for Combidex, an MRI contrast agent. The company’s European marketing partner, Guerbet, has also submitted the European equivalent of an NDA to the European Medicines Evaluations Agency. Combidex is Advanced Magnetics’ third product.

The company’s U.S. NDA covers two indications: the diagnosis of lymph node disease and the detection, diagnosis, and evaluation of benign and malignant lesions of the liver and spleen. Advanced Magnetics hopes to receive priority review from the FDA for its Dec. 21 application, which would precipitate an action letter from the FDA six months from the application date rather than 12. Guerbet expects to launch Combidex in Europe in early 2001 under the trade name Sinerem.

The company hopes Combidex will help oncologists and radiologists to noninvasively stage metastatic cancer in lymph nodes. Advanced Magnetics plans to find a marketing partner for the agent, according to the Cambridge, MA-based firm.

Related Videos
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Can Diffusion Microstructural Imaging Provide Insights into Long Covid Beyond Conventional MRI?
Assessing the Impact of Radiology Workforce Shortages in Rural Communities
Emerging MRI and PET Research Reveals Link Between Visceral Abdominal Fat and Early Signs of Alzheimer’s Disease
Reimbursement Challenges in Radiology: An Interview with Richard Heller, MD
Nina Kottler, MD, MS
The Executive Order on AI: Promising Development for Radiology or ‘HIPAA for AI’?
Related Content
© 2024 MJH Life Sciences

All rights reserved.