Mallinckrodt agent ready for market

September 11, 1996

The first nonionic x-ray contrast agent developed in the U.S. was approved for market by the Food andDrug Administration earlier this month. Optiray, a low-osmolalitynonionic contrast agent manufactured by Mallinckrodt, should reachthe market this

The first nonionic x-ray contrast agent developed in the U.S. was approved for market by the Food andDrug Administration earlier this month. Optiray, a low-osmolalitynonionic contrast agent manufactured by Mallinckrodt, should reachthe market this spring, after the company initiates the new productionprocess. The agent, whose chemical name is ioversol, will be soldinitially for computed tomography, angiography, and urographyapplications, a Mallinckrodt spokesperson said.

Mallinckrodt will market Optiray along with Hexabrix, a low-osmolalityionic contrast agent developed by the French pharmaceutical companyGuerbet. Hexabrix has been on the U.S. market for three years.Omnipaque, a nonionic agent developed by Nycomed of Oslo, Norway,is marketed by Kodak's Winthrop Pharmaceuticals in the U.S.

"The market for contrast media is growing rapidly andan increasing portion of it is shifting to new-generation, low-osmolalityproducts, both nonionic and ionic," said Carl Holman, presidentof Mallinckrodt Medical.

The high cost of these new radiographic contrast agents hasrestrained the market. Mallinckrodt hopes to provide its own nonioniccontrast agent at a lower price than European imports, therebystimulating clinical demand (SCAN 2/17/88). The price of Optiray,however, has not been announced.

Mallinckrodt estimates the current U.S. market for x-ray contrastmedia at $500 million per year and forecasts that sales will reach$1 billion by 1993. U.S. sales constitute about half of the worldwidemarket.

The relatively speedy approval for Optiray was welcomed byMallinckrodt. It had filed for approval with the FDA in June 1987.The most optimistic company projection for the final market go-aheadwas "sometime in 1989."

"Despite increasing demand on limited resources, the FDAprovided a timely review of Optiray, which was a large and complicatednew drug application," said Dr. Edward Aten, vice presidentfor medical affairs.