MALLINCKRODT OPTIRAY APPROVAL COMPLEMENTS HEXABRIX LOW OSMOLALITY

MALLINCKRODT OPTIRAY APPROVAL COMPLEMENTS HEXABRIX LOW OSMOLALITY contrast media line. In a Jan. 4 announcement of the Optiray (ioversol) approval, Mallinckrodt noted that the addition of the nonionic imaging agent makes the firm "the only U.S. company to offer a complete line of low osmolality contrast media." Hexabrix (ioxaglate megulamine), the first ionic low osmolality product approved in the U.S., was introduced by Mallinckrodt in September 1985. Mallinckrodt received FDA approval on Dec. 30 for three Optiray formulations - Optiray-160 (iverosol injection 34%), Optiray-240 (51%), and Optiray-320 (68%). The approved labeling notes that Optiray-320 is indicated "for angiography throughout the cardiovascular system [including] cerebral, coronary, peripheral, visceral and renal arteriography, aortography, and left ventriculography." Optiray-320 is also indicated for "contrast enhanced" CT imaging "of the head and body, and I.V. excretory urography." Optiray-240 carries claims for cerebral angiography and venography, while Optiray-160 is approved for "intra-arterial digital subtraction angiography." The Mallinckrodt press release indicates a spring launch for the new product. The company "has begun initial production of Optiray and will proceed through several months of production scale-up, followed by market introduction," Mallinckrodt noted. Optiray will be the third nonionic imaging agent to reach the U.S. market after Squibb's Isovue and Sterling's Omnipaque, which had estimated 1988 sales of $150 mil. and $200 mil., respectively. Mallinckrodt estimates the entire U.S. market for x-ray contrast media to be $500 mil. with the worldwide market at about $1 bil. The company expects additional marketing approvals during 1989 in several "key European countries, Canada and Australia," the release notes. Unlike Squibb and Sterling, whose products are licensed from European companies, Mallinckrodt has worldwide rights to Optiray. Mallinckrodt also manufactures conventional contrast media products, including its Conray (iothalmate meglumine) line and a multisource line introduced in the early 1980's. Adverse reactions in Optiray's labeling are described as "mild to moderate." The most severe side effects, angina pectoris, cerebral infarct, hypotension, nausea, headache, and other reactions, the labeling notes, occur in less than 1% of patients. In addition, the labeling points out that contrast media injections are often associated with "sensations of warmth and pain." The labeling adds that "significantly less warmth and pain were associated with the injection of Optiray than with iothalamate meglumine [Conray], diatrizoate meglumine [Berlex's Angiovist 282 and Squibb's Cardiografin], and diatrizoate sodium." Optiray was one of two new contrast imaging agents to be approved in FDA's end of the year rush of approvals ("The Pink Sheet" Jan. 2, p.18). A stroke detector adjunct, Amersham's Ceretec (technetium 99m HMPAO or exametazine) was also approved in December. Earlier this year, in June, FDA approved Berlex Labs' Magnevist (gadopentetate dimeglumine).