FDA says AMI agent is approvable

Article

MRI contrast developer Advanced Magnetics of Cambridge, MA, hasscored its second approvable letter this year from the Food andDrug Administration. AMI announced this month that the agencyhas indicated that its Gastromark agent for MRI of the

MRI contrast developer Advanced Magnetics of Cambridge, MA, hasscored its second approvable letter this year from the Food andDrug Administration. AMI announced this month that the agencyhas indicated that its Gastromark agent for MRI of the gastrointestinaltract is approvable. The FDA issued a similar letter earlier thisyear for AMI's Feridex IV agent (SCAN 2/14/96).

Final FDA approval of Gastromark will trigger a milestone paymentto AMI from Mallinckrodt Medical, which has rights to the productin the U.S., Canada, and Mexico. Guerbet of France markets theproduct in Western Europe as Lumirem.

In other AMI news, the company has decided to take advantage ofthe recent drop in its stock price by authorizing a plan to buyback 250,000 of its 6.8 million shares outstanding.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
CT-Based Deep Learning Model May Reduce False Positives with Indeterminate Lung Nodules by Nearly 40 Percent
Leading Breast Radiologists Discuss Rise of Breast Cancer Incidence in Women Under 40
New Research Examines Radiation Risks with CT Exposure Prior to Pregnancy
© 2025 MJH Life Sciences

All rights reserved.