FDA clears Mallinckrodt's OptiMark contrast agent

Contrast developer Mallinckrodt of St. Louis received good news this month from the Food and Drug Administration when the agency cleared the company's MRI contrast agent, OptiMark. The approval gives Mallinckrodt a general-purpose MRI contrast product to compete with agents on the market from Schering, Nycomed Amersham, and Bracco.

OptiMark is indicated for increased enhancement and visualization of lesions of the brain, spine and liver, including tumors. OptiMark shipments should begin in the first quarter of 2000.

The market for general-purpose MRI contrast agents is worth $150 million, and is growing at a rate of 12 to 15 percent a year, according to Bradley Fercho, president of Mallinckrodt's imaging group. Mallinckrodt intends to emphasize the strength, versatility, and efficacy of OptiMark, rather than compete on price, according to Fercho. The contrast agent market has experienced serious price erosion in recent years.

Mallinckrodt already sells one MRI contrast agent, GastroMark, for gastrointestinal applications. The company is co-developing a cardiac MRI agent, AngioMark, in collaboration with Epix Medical of Cambridge, MA.

By Brian Casey
AuntMinnie.com staff writer
December 10, 1999
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