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US FDA Approves Lantheus Medical Imaging's Definity Label Update.

M2 PHARMA-February 3, 2017-US FDA Approves Lantheus Medical Imaging's Definity Label Update


- US-based diagnostic imaging agents and products Lantheus Medical Imaging, Inc. has received US Food and Drug Administration approval of an important label update for Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension which removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the US Prescribing Information, the company said.

Definity is 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.

A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal path of the circulatory system, which may present in 10% to 35% of patients.

These patients were previously excluded from receiving a valuable echo contrast study of the left ventricle.

The FDA's decision to remove the contraindication concerning known or suspected cardiac shunts was based on Lantheus' submission referencing several publications and data supporting the safety of echocardiography contrast products in patients with cardiac shunts.

Information concerning administration in patients with a cardiac shunt appears in the Warnings section of the Definity Prescribing Information.

Up to 20% of all resting echocardiography studies and up to 30% of those conducted in critical care patients can result in suboptimal echocardiograms.

A suboptimal image is one in which two or more contiguous left ventricular segments in any of the three apical views cannot be visualized.

The use of contrast in suboptimal echocardiograms may help with clinical evaluation of the patient.

Lantheus Medical Imaging, Inc., a subsidiary of Lantheus Holdings, Inc. (NASDAQ: LNTH), is in the development, manufacture and commercialisation of innovative diagnostic imaging agents and products. Lantheus provides a portfolio of products, which are primarily used for the diagnosis of cardiovascular diseases.

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Publication:M2 Pharma
Date:Feb 3, 2017
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