Free at last--thank the FDA

The Food and Drug Administration has a habit of approving drugsat the end of the year. An FDA panel had advised a marketing go-aheadfor CardioTec and Cardiolite, technetium-labeled nuclear cardiacimaging agents offered by Squibb and Du Pont, respectively. Thecompanies hoped that agency clearance for sales of their agentswould come before the new year (SCAN 12/27/89).

It did--but unfortunately, the companies had the year wrong.

After a year of treading water while awaiting a final signaturefrom the FDA, the marketing staffs of both companies receivedapproval for sales of CardioTec and Cardiolite last month.

The two myocardial perfusion imaging agents can be used forboth planar and single-photon emission computed tomography imaging.They have been approved for slightly different indications, however.

CardioTec is approved for use primarily in distinguishing normalfrom abnormal myocardia in patients with suspected coronary arterydisease.

Cardiolite will initially have more limited use in the diagnosisand localization of myocardial infarction in coronary artery disease.However, Du Pont projects that Cardiolite will be used in 40%of all cardiac imaging studies within five years. About two millionstudies are performed annually, 1.5 million of which use thallium,the company said.

The number of cardiac stress exams may increase further asa result of another product approval the FDA granted this month.Du Pont won market certification for IV Persantine, its pharmacologicalstressor (SCAN 9/12/90).

The regulatory approvals come at a convenient time for Du Pont,which initiated its pharmaceutical joint venture with Merck thismonth. An agreement to form Du Pont Merck Pharmaceutical was reachedlast summer (SCAN 8/15/90). Joseph A. Mollica has been named presidentof the merged company.

Squibb Diagnostics is also part of a larger company, Bristol-MyersSquibb, formed by the merger of two pharmaceutical firms.