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The FDA has recently granted a class labeling change to Lantheus Medical Imaging's Definity®, based on Prescribing Information revisions effectively modifying the FDA's benefit/risk assessment. The previous labeling, initially introduced in October 2007, had a profound impact on Definity® use based on an independent survey of the community at EchoChief.com From October 2007 just after the initial FDA "black box" warning until June 2008, we asked the community at EchoChief.com to tell us how the October 2007 labeling would impact their use of Definity®. Just over %50 said they were "significantly reducing" while %23 said they "completely eliminated" the use of Definity®. Most agree the new labeling strikes a better balance between patient safety and clinical needs to improve diagnostic confidence. The challenge now is to communicate to the physicians and staff about the revised labeling and what it means in practical terms to their practice patterns. It will take a few months to gauge how quickly users come back to the use of contrast agents in general and Definity® in particular. Much has been happening in the ultrasound contrast agent market. In case you missed it Definity® is now owned by Lantheus Medical Imaging, whose parent compnay is Avista Capital Partners. Both Bracco (SonoVue®) and GE Healthcare (OPTISON™) hope to have their agents FDA approved with similar labeling soon. Another company, Acusphere, has filed a NDA with the FDA for their ultrasound contrast agent (magify™). If approved Acusphere's magify™ would be the first ultrasound contrast agent approved for detection of coronary artery disease. While we encourage you to read the entire packaging details.

ultrasound, contrast, agents, echocardiography, definity, fda,