FDA says AMI agent is approvable
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.