Lantheus Holdings, Inc. Announces FDA Approval of DEFINITY® Room Temperature
Commercially Available in Early 2021
“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
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
The composition of matter
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
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension
Activated DEFINITY® and activated DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Do not administer DEFINITY® and DEFINITY® RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration.
In post-marketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please see accompanying full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) our future operating results; (ii) the impact of the COVID-19 pandemic on our business, financial condition and prospects; (iii) the Company’s ability to successfully launch DEFINITY RT as a commercial product and the timing of the launch; (iv) the intellectual property protection of DEFINITY RT; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; and (vi) the risk and uncertainties discussed in our filings with the
1 DEFINITY® (Package Insert),
2 DEFINITY® RT (Package Insert),
3 Data on file,
Reprinted with permission.
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Director, Corporate Communications