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

The FDA has approved Lilly’s TAUVID (flortaucipir F 18 injection), a radioactive diagnostic agent, for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease

Getty Images

News | Contrast Media | June 01, 2020
June 1, 2020 — TAUVID, a radioactive diagnostic agent, has been approved by the FDA for...
The Philips Lumify point-of-care ultrasound (POCUS) system assessing a patient in the emergency room combined with telehealth to enable real-time collaboration with other physicians.

The Philips Lumify point-of-care ultrasound (POCUS) system assessing a patient in the emergency room combined with telehealth to enable real-time collaboration with other physicians.

News | Coronavirus (COVID-19) | May 26, 2020
May 26, 2020  — Philips Healthcare recently received 510(k) clearance from the U.S.
An example of DiA'a automated ejection fraction AI software on the GE vScan POCUS system at RSNA 2019.

An example of DiA'a automated ejection fraction AI software on the GE vScan POCUS system at RSNA 2019. Photo by Dave Fornell.

News | Ultrasound Imaging | May 26, 2020
May 12, 2020 — DiA Imaging Analysis, a provider of AI based ultrasound analysis solutions, said it received a governm
Researchers from Tokyo Metropolitan University have surveyed the amount of gadolinium found in river water in Tokyo. Gadolinium is contained in contrast agents given to patients undergoing medical magnetic resonance imaging (MRI) scans, and it has been shown in labs to become toxic when exposed to ultraviolet rays. The researchers found significantly elevated levels, particularly near water treatment plants, highlighting the need for new public policy and removal technologies as MRI become even more commonp

Samples were taken along rivers around Tokyo. Measurements of rare earth element quantities indicate a clearly elevated amount of gadolinium compared to that in natural shale. Graphics courtesy of Tokyo Metropolitan University

News | Magnetic Resonance Imaging (MRI) | May 26, 2020
May 26, 2020 — Researchers from Tokyo Metropolitan...
Butterfly iQ devices provide revolutionary portable ultrasound capabilities for faster and easier screening and monitoring
News | Coronavirus (COVID-19) | May 20, 2020
May 20, 2020 —Atrium Health is one of the first major health systems in the nation to put into wide practice a new...
Richard J. Price, Ph.D., of the University of Virginia's School of Medicine and School of Engineering, is using focused soundwaves to overcome the natural 'blood-brain barrier,' which protects the brain from harmful pathogens. Photo courtesy of Dan Addison | UVA Communications

Richard J. Price, Ph.D., of the University of Virginia's School of Medicine and School of Engineering, is using focused soundwaves to overcome the natural 'blood-brain barrier,' which protects the brain from harmful pathogens. Photo courtesy of Dan Addison | UVA Communications

News | Focused Ultrasound Therapy | May 07, 2020
May 7, 2020 — University of Virginia researchers are pioneering the use of...
The new transducer reaches a 30% greater penetration, so clinicians have detailed images and performance they need to make a definitive diagnosis for pediatric patients, reducing the need for additional diagnostic imaging steps
News | Pediatric Imaging | May 06, 2020
May 6, 2020 — Philips announced the ...
Konica Minolta Healthcare's Rede Mini PACS are designed for specialty practices such as orthopedic, urgent care and family medicine clinics
News | PACS | April 28, 2020
April 28, 2020 – Konica Minolta Healthcare Americas released its Rede...