FDA Approves Definity Labeling Removing Contraindication
Lantheus Medical Imaging announced that the Food and Drug Administration (FDA) has approved a label update for Definity (perflutren lipid microsphere) injectable suspension with the removal of a contraindication related to use in patients with a known or suspected cardiac shunt.
The removal of the contraindication concerning known or suspected cardiac shunts was based on the submission of data supporting the safety of echocardiography contrast products in patients with cardiac shunts. The Warnings and Precautions section has been updated with information about administration in patients with a cardiac shunt.
Definity, an ultrasound contrast agent, is approved for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. The lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. These physical acoustic properties of activated Definity provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography.
Definity for injectable suspension is available as single-use 2mL vials in 1-, 4-, and 16-count kits.
For more information call (800) 362-2668 or visit DefinityImaging.com.