Lantheus Medical Imaging said that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental new drug application (sNDA) to deploy its Definity echocardiography contrast agent in stress echocardiography studies.
The FDA will now review the application to determine whether or not to broaden Definity's approved indication to include its use with exercise and pharmacologic stress testing, according to the North Billerica, MA-based vendor.
Definity is currently indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
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