MALLINCKRODT's HEXABRIX IS A 1C APPROVAL

Executive Summary

MALLINCKRODT's HEXABRIX IS A 1C APPROVAL indicated for cerebral angiography, peripheral arteriography, selective visceral arteriography and selective coronary arteriography with or without left ventriculography, according to the FDA-approved labeling for the injectable x-ray contrast medium. Hexabrix was approved by the agency July 26 after a 46 month review. The lC rating signifies a new molecular entity representing little or no therapeutic gain. Mallinckrodt noted that approximately 12 mil. procedures requiring the use of contrast media are performed annually. The firm said that the product would be available in early September. In a press release announcing approval of the diagnostic, Mallinckrodt said, "Hexabrix represents a new generation of new low-osmolality iodinated contrast media which are better tolerated by patients than the older products available to the medical community." The firm explained that "some of the side effects associated with the injectable iodinated x-ray contrast media are related to the relatively high osmolality ]number of particles relative to volume of the solution[ of the solution."