The US Food and Drug Administration (FDA) has approved Lantheus Holdings’ supplemental new drug application (sNDA) for VIALMIXRFID and DEFINITY.
VIALMIXRFID is an activation device designed for DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension and DEFINITY modified formulation product candidate.
DEFINITY Vial for (perflutren lipid microsphere) injectable suspension is an ultrasound enhancing agent. It is indicated for use in patients with suboptimal echocardiograms.
It is supplied as a liquid-filled glass vial and needs to be activated in order to create the lipid-encapsulated microbubbles.
VIALMIXRFID is developed to control the activation rate and time, using radio-frequency identification technology to guarantee the reproducible activation of DEFINITY.
DEFINITY vial can be activated by using RFID tag, which is affixed to the vial label, along with VIALMIXRFID activation device.
Lantheus Holdings president and CEO Mary Anne Heino said: “The approval of VIALMIXRFID strengthens and extends our core microbubble franchise.
“By controlling the activation rate and time, the RFID technology ensures reproducible activation of DEFINITY and reduces risks related to the 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.”
Last year, Lantheus entered a strategic partnership with France-based CarThera to expand the use of its microbubbles for treatment of glioblastoma.
The company partnered with GE Healthcare in 2017 for the development and commercialisation of ‘flurpiridaz F 18’ for the enhanced diagnosis of coronary artery disease (CAD).