Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal cardiograms.
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.
With the acceptance, the FDA will review the sNDA to determine whether or not to broaden the FDA-approved indication for Definity to include its use with exercise and pharmacologic stress testing.
Lantheus Medical Imaging president and CEO Don Kiepert said the submission of the sNDA reaffirms their commitment to expanding the indication for the use of Definity in patients with suboptimal echocardiograms, and emphasizes the important role that contrast echocardiography can play in the diagnosis and management of cardiac conditions, particularly among difficult-to-image patients or when the clinical question at hand cannot be easily answered.
"Definity has a proven safety profile and demonstrated efficacy, and we look forward to the FDA’s review of our application for the expanded use of Definity for stress echocardiography," Kiepert said.
