N. BILLERICA, Mass.--(BUSINESS WIRE)--
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced important changes to the U.S. product label for DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension. Based on an extensive and thorough review of recent safety information provided to the FDA by both Lantheus and members of the echocardiography community, the Prescribing Information revisions modify DEFINITY®’s benefit/risk assessment. The DEFINITY® label changes the FDA approved today supercede the FDA-mandated label changes that Lantheus announced in October 2007 and include revisions to the boxed WARNING, WARNINGS and CONTRAINDICATIONS sections of the prescribing information. Similar label updates have been approved by the FDA for all perflutren-containing microsphere contrast agents.
