News | March 14, 2013

FDA Approves Jubilant HollisterStier as New Manufacturer for Definity Ultrasound Contrast Agent

March 14, 2013 — Lantheus Medical Imaging Inc. announced the U.S. Food and Drug Administration (FDA) has granted approval of a supplemental new drug application (sNDA) that allows Jubilant HollisterStier (JHS) to be a new manufacturing site for its ultrasound imaging agent, Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension.

Definity is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

“FDA approval of JHS as a new manufacturer for Definity is a major step forward in providing consistent and reliable supply to our customers,” said Jeff Bailey, Lantheus president and CEO. “Supply chain diversification is a significant priority for the company as we work to ensure long-term product availability to meet market demand. We remain dedicated to providing the highest quality products to our customers and the patients they serve.”

Definity is currently manufactured by Ben Venue Laboratories (BVL) in Bedford, Ohio. In August 2011, BVL announced it would exit the contract manufacturing services business over the next several years. In February 2012, Lantheus entered into a manufacturing and supply agreement with JHS for the manufacture of Definity. Additionally, the company entered into similar agreements with JHS in May 2012 for the manufacture and supply of Cardiolite and Neurolite, which are also currently manufactured by BVL. JHS will become Lantheus’s lead supplier of Definity, as well as Cardiolite and Neurolite, as BVL transitions out of the contract manufacturing services business. Lantheus is currently working to secure additional alternative suppliers for its key products as part of its ongoing supply chain diversification strategy.

For more information: www.definityimaging.com

Related Content

Bayer Introduces Medrad Stellant Flex CT Injection System
Technology | Contrast Media Injectors | September 11, 2019
Bayer announced the introduction of the Medrad Stellant Flex computed tomography (CT) injection system. Stellant Flex...
ASNC Announces Multisocietal Cardiac Amyloidosis Imaging Consensus
News | Cardiac Imaging | September 09, 2019
September 9, 2019 — The American Society of Nuclear Cardiology (ASNC) published a new expert consensus document along
Characteristics nephrologists associate with renal high-risk patients. (n=13)

Characteristics nephrologists associate with renal high-risk patients. (n=13)

Feature | Contrast Media | September 05, 2019
The global rise in chronic disease has significantly increased demand for diagnostic imaging procedures, and in turn,
Medical Imaging Rates Continue to Rise Despite Push to Reduce Their Use
News | Radiology Imaging | September 03, 2019
Despite a broad campaign among physician groups to reduce the amount of medical imaging, use rates of various scans...
News | Contrast Media | September 03, 2019
Researchers in South Korea have found that patients with family and personal history of allergic reactions to contrast...
Philips Debuts Cardiac Ultrasound and Enterprise Informatics Offerings at ESC 2019
News | Cardiac Imaging | August 30, 2019
Philips will showcase its latest cardiac care innovations at the European Society of Cardiology (ESC) Congress 2019,...
CIRS Launches Ultrasound Quality Assurance Software
Technology | Quality Assurance (QA) | August 30, 2019
August 30, 2019 — The CIRS Ultrasound...
Displacement comparison at the end-systolic frame and final frame

Displacement comparison at the end-systolic frame and final frame. The three patients (V6, V10, V16) with different left-ventricle walls are shown. Point-to-surface distance is a measure to estimate the distance of a point from the reference surface. Image courtesy of WMG, University of Warwick

News | Cardiac Imaging | August 28, 2019
A new 3-D magnetic resonance imaging (MRI) computing technique developed by scientists in WMG at the University of...
Terason Partners With DiA Imaging Analysis for Point-of-care Cardiac Ultrasound AI
News | Cardiovascular Ultrasound | August 26, 2019
Ultrasound imaging company Terason has partnered with DiA Imaging Analysis, provider of artificial intelligence (AI)-...
Exo Imaging Raises $35 Million for Developmental Ultrasound Platform
News | Ultrasound Imaging | August 23, 2019
Exo Imaging Inc. announced a $35 million Series B financing round for its high-performance ultrasound platform based on...