NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Aug. 12, 2020-- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for VIALMIX®RFID for DEFINITY®.

VIALMIXRFID is a next generation activation device designed specifically for DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an intravenous ultrasound enhancing agent, and our DEFINITY modified formulation product candidate. DEFINITY is supplied as a liquid-filled glass vial and requires activation in order to create the lipid-encapsulated microbubbles. The activation rate and time are controlled by VIALMIXRFID through the use of radio-frequency identification technology to ensure reproducible activation of DEFINITY. The RFID tag, which is affixed to the vial label, enables the DEFINITY vial to be appropriately activated when utilized with VIALMIXRFID activation device.

“The approval of VIALMIXRFID further strengthens and extends our core microbubble franchise,” said Mary Anne Heino, President and Chief Executive Officer. “By controlling the activation rate and time, the RFID technology ensures reproducible activation of DEFINITY and reduces risks related to operator or medication errors, potentially increasing patient safety. Importantly, VIALMIXRFID has been designed to work with our currently approved DEFINITY vial and our DEFINITY modified formulation product candidate. I am grateful to the entire Lantheus team that worked tirelessly to bring this next generation activation device to the market.”
A U.S. issued patent on the use of the new VIALMIXRFID with an expiration date of 2037 has been listed in the Orange Book, and additional patent applications have been submitted in major markets throughout the world.


About DEFINITY®
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is an ultrasound enhancing agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1 DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1 DEFINITY has extensive safety experience and a consistent safety profile.2 Since its launch in 2001, more than 13 million echo studies have been performed with DEFINITY and it is the most prescribed ultrasound enhancing agent in the U.S.3

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