The History of Product Label Changes for DEFINITY® in the US

Abstract

DEFINITY® (Perflutren Lipid Microsphere Injectable Suspension, Lantheus Medical Imaging, North Billerica, MA) was approved by the US Food and Drug Administration in 2001 for “opacification of the left ventricular border in patients with technically difficult echocardiograms”. Since then, product labeling has been substantially revised on three occasions, initially due to safety concerns, and more recently to reflect a large body of literature which supports the excellent risk–benefit profile of this agent. This article describes in detail the substantive modifications of the product labeling for DEFINITY since 2001, and the associated supportive scientific data and public regulatory meetings.