Lantheus Holdings, Inc. Announces FDA Approval of DEFINITY® Room Temperature

Lantheus Holdings announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® Room Temperature (DEFINITY RT) (Perflutren Lipid Microsphere) Injectable Suspension.

“With the approval of DEFINITY RT, we expand our microbubble franchise offering to include a room temperature formulation, in addition to our market leading, refrigerated DEFINITY that our customers and patients have trusted to enhance suboptimal echocardiograms for 19 years. This approval will enable those customers who prefer a non-refrigerated product to be able to continue to benefit from our DEFINITY microbubble products,” said Paul Blanchfield, Chief Commercial Officer.

Mary Anne Heino, President and Chief Executive Officer, added, “We continue to expand the offerings in our microbubble franchise. The addition of DEFINITY RT recognizes the increasing need for portability in delivery of healthcare services, as well as our commitment to partnering with innovators developing complex product formulations which include a microbubble. I am thankful to the entire Lantheus team who worked diligently to bring this new formulation to the market.”

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.

The composition of matter U.S. issued patent for DEFINITY RT has an expiration date of 2035 and will be listed in the Orange Book.

About DEFINITY® and DEFINITY® RT

DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension and DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension (activated) are ultrasound enhancing agents for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1,2 DEFINITY and DEFINITY RT are engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1,2 DEFINITY has extensive safety experience and a consistent safety profile.3 Since its launch in 2001, more than 14 million echo studies have been performed with DEFINITY, and it is the most prescribed ultrasound enhancing agent in the U.S.4

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