Lantheus announces FDA approval of DEFINITY for pediatric patients

Lantheus Holdings announced that the U.S. Food and Drug Administration, FDA, has approved the supplemental new drug application, sNDA, for DEFINITY as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. The FDA decision was based on usage data from three pediatric clinical trials conducted with DEFINITY: the Golding study; the Fine study, which evaluated 36 patients, ranging from 10 to 21 years of age, who had previously undergone a heart transplant; and the Kutty study.