Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patients
Lantheus Holdings, Inc, has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Definity® (Perflutren Lipid Microsphere) 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. Currently, Definity is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.
Clinical studies have substantiated the efficacy and safety of Definity in pediatric patients.
