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 single-photon 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.
INDICATIONS
NEUROLITE single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging 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.
CONTRAINDICATIONS
None known.
Important Safety Information
In clinical trials, NEUROLITE has been administered to 1063 subjects (255 normals, 808 patients). In the 808 patients with neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to NEUROLITE. The following adverse effects were observed in < 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.