FDA gives Lantheus nod for Neurolite manufacturing

The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Neurolite, Lantheus Medical Imaging's technetium-based SPECT radiopharmaceutical agent.

The clearance allows Jubilant HollisterStier to be a new manufacturing site for Neurolite, which will ensure a long-term and sufficient supply of the agent, Lantheus said. Jubilant HollisterStier also manufactures Lantheus Medical's Definity ultrasound contrast agent.

Jubilant HollisterStier has been approved as a manufacturer for Neurolite by the Therapeutic Goods Administration of Australia and the Pharmaceuticals and Medical Devices Agency of Japan, according to the firm.