News | February 04, 2015

Jubilant HollisterStier Approved by FDA to Manufacture Lantheus' Neurolite

JHS joins growing network for brain imaging agent

Lantheus, Jubilant HollisterStier, Neurolite, manufacturing, radiopharmaceutical

Image courtesy of Lantheus Medical Imaging Inc.

February 4, 2015 — Lantheus Medical Imaging Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) allowing Jubilant HollisterStier (JHS) to be a new manufacturer for its proprietary brain perfusion imaging agent Neurolite. Neurolite is a technetium-based single-photon emission computed tomography (SPECT) radiopharmaceutical agent used to identify the area within the brain where blood flow has been blocked or reduced due to stroke.

The radiotracer is indicated as an adjunct to conventional computed tomography (CT) or magnetic resonance imaging (MRI) in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue or for distinguishing between stroke and other brain lesions.

Recently, Lantheus received approval from the Therapeutic Goods Administration (TGA) of Australia and the Pharmaceutical and Medical Devices Agency of Japan for JHS-manufactured Neurolite.

For more information: www.lantheus.com

Related Content

ASNC and ASE Team Up to Expand ImageGuide Registry
News | Cardiovascular Ultrasound | October 12, 2017
The American Society of Nuclear Cardiology (ASNC) and the American Society of Echocardiography (ASE) jointly announced...
MR Solutions Showcases Multimodality MRI Solutions on Two Continents
News | Magnetic Resonance Imaging (MRI) | October 11, 2017
October 11, 2017 — MR Solutions took their cryogen-free preclinical multimodality...
Majority of Recurrent Prostate Cancer Patients' Treatment Plan Changed Following Fluciclovine 18F PET/CT
News | Prostate Cancer | October 04, 2017
Blue Earth Diagnostics recently announced the results of a pre-planned interim analysis from an investigational...
News | Business | September 19, 2017
September 19, 2017 — Invicro LLC, a provider of imaging services and software for research and drug development, anno
ScImage and Invia Partnership Announced
News | PACS | September 19, 2017
ScImage Inc. and Invia Imaging Solutions recently announced formation of a joint partnership at the American Society of...
Toshiba Highlights Latest CT Advancements at RSNA 2017
News | Computed Tomography (CT) | September 18, 2017
Toshiba Medical announced that it will display several new enhancements to its existing computed tomography (CT)...
Philips Launches CardioMD IV Cardiac SPECT Solution at ASNC 2017
Technology | SPECT Imaging | September 15, 2017
September 15, 2017 — Philips highlighted its newest solution for...
Double Targeting Ligands to Identify and Treat Prostate Cancer

The mice were imaged with small-animal PET/CT using 124I-RPS-027 (7.4 MBq [200 μCi]). Credit: JM Kelly et al., Department of Radiology, Weill Cornell Medicine, New York, NY

News | Prostate Cancer | September 14, 2017
Researchers have demonstrated a new, effective way to precisely identify and localize prostate cancer tumors while...
Blue Earth Diagnostics Announcing Results of FALCON PET/CT Trial at ASTRO 2017
News | PET-CT | September 13, 2017
September 13, 2017 — Blue Earth Diagnostics announced the upcoming oral presentation of initial results from the FALC
FDG-PET/CT Predicts Melanoma Patients' Response to Immune Checkpoint Inhibitor Therapy
News | PET-CT | September 07, 2017
September 7, 2017 — Advanced melanoma has a poor prognosis, but immune checkpoint inhibitor therapy can be effective
Overlay Init