Jubilant HollisterStier Approved by FDA to Manufacture Lantheus' Neurolite

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