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# Lantheus sNDA Approved for Definity Pediatric Use
- URL: https://www.fdaweb.com/lantheus-snda-approved-for-definity-pediatric-use/
- Published: 2024-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:24:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156497

FDA has approved a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid microsphere) in pediatric patients with suboptimal echocardiograms. The approval offers a “valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border,” the company says.

The expanded use was based on usage data from three pediatric clinical trials — the Golding study, the Fine study,and the Kutty study. “The Golding study, together with supportive data from the Fine and Kutty studies, demonstrated that left ventricular opacification with Definity (cumulative doses ranging from 6 µL/kg to 20 µL/kg) is successful in pediatric patients and that ultrasound contrast provides important information to guide management in such patients,” Lantheus says.

Lantheus notes that all reported adverse events across all trials were mild, brief and reversible without intervention.