Lantheus announces FDA approval of Definity room temperature

Lantheus

18 November 2020 - Lantheus today announced the U.S. FDA has approved the supplemental new drug application for Definity Room Temperature (Definity RT) (perflutren lipid microsphere) injectable suspension.

Definity RT is a modified formulation of Definity that allows both storage and shipment at room temperature (Definity’s previously approved formulation requires refrigerated storage). The activation of Definity RT will be achieved using the Vialmix RFID device, which was approved in August 2020. 

This modified formulation provides clinicians an additional choice and allows for greater utility of this formulation in broader clinical settings.

Read Lantheus press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US