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Executive Summary

FDA's traditional flurry of December NDA approvals this year includes two nonionic contrast media agents for diagnostic imaging: Sterling's Omnipaque (iohexol) and Squibb's Isovue (iopamidol). In announcing the approval of its product, Sterling stated, "Omnipaque brings a new level of safety and comfort to patients undergoing examinations in which contrast media are used." The company said that in the largest clinical study, which involved 50,000 patients in West Germany, 97.8% of those injected with Omnipaque experienced none of the adverse effects, including pain, nausea, and kidney damage, often associated with other contrast media. Sterling began shipping Omnipaque immediately after receiving its Dec. 27 approval. The product is used in x-ray and computerized tomographic visualization of organs, arteries, veins, and the spinal cord and will be available in iodine concentrations of 180, 240, 300 and 350 mgi/ml (milligrams of iodine per milliliter). Wholesale prices will range from $37.07 per 10 ml vial of Omnipaque to $49 per 50 ml vial of the 350 mgi/ml concentration. With marketing approval for Omnipaque, Sterling has received four new FDA drug approvals in the past 1-1/2 years. The other three new prescription products are Inocor I.V. brand of amrinone for the treatment of congestive heart failure, Tornalate brand of bitolterol, a long-acting aerosol bronchodilator, and Modrastane brand of trilostane for the treatment of Cushing's syndrome. Squibb's Isovue (iopamidol) and Isovue-M (iopamidol injection) nonionic contrast media were approved Dec. 31 after a 33 month review. A company press release announced that Isovue, licensed from the Italian firm Bracco and to be marketed by Squibb Diagnostics, will be available within two weeks. Isovue is recommended for use in angiography, while Isovue-M is recommended for use in myelography, Squibb said. According to the release, "both products will be used in a wide variety of x-ray procedures, including computer tomography." The firm said that "spinal cord radiologic uses of Isovue-M include lumbar, thoracic, cervical and total columnar myelography," and "intravascular uses of Isovue include coronary angiography and ventriculography, peripheral arteriography and ventriculography, peripheral arteriography, cerebral arteriography and CT scanning of the head and body." The two Isovue concentrations -- 300 (61% iopamidol) and 370 (76% iopamidol) are retail priced at $45.90 and $50, respectively, for 50 ml vials. The 200 (41%) concentration of Isovue-M will cost $44.10 per 20 ml vial and the 300 (61%) Isovue-M will be $44.90 per 20 ml vial.

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