No. BILLERICA, Mass. (January 29, 2015) - Lantheus Medical Imaging, Inc. (Lantheus), a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents, today announced that 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 proprietary brain perfusion imaging agent NEUROLITE® (Kit of the Preparation of Technetium Tc99m Bicisate for Injection). NEUROLITE, a technetium-based singlephoton emission computed tomography (SPECT) radiopharmaceutical agent, provides healthcare providers with critical neurological information for patients.
"FDA approval of JHS as a new manufacturer for NEUROLITE is a major step forward in ensuring that there is long-term, sufficient supply of NEUROLITE available to meet market demand for brain perfusion imaging agents," said Jeff Bailey, President and CEO of Lantheus. "We are pleased to partner with JHS for the manufacture of high quality products, including NEUROLITE and DEFINITY."
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. JHS also serves as an approved manufacturer of DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension for contrast-enhanced echocardiography.
About NEUROLITE
NEUROLITE (Kit of the Preparation of Technetium Tc99m Bicisate for Injection) is a SPECT brain imaging agent for use to identify the area within the brain where blood flow has been blocked or reduced due to stroke.
