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# Lantheus NDA for Imaging Agent Accepted
- URL: https://www.fdaweb.com/lantheus-nda-for-imaging-agent-accepted/
- Published: 2025-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:25:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160139

FDA has accepted for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotreotide injection, indicated for use with positron emission tomography imaging for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients. Submitted under FDA’s 505(b)(2) pathway, the filing “builds on an extensive evidence base for Ga-68 edotreotide, including multiple published studies,” the company says. The agency has set a user fee review action date of 3/29/2026.

NETs are described as rare, often slow-growing cancers that can develop throughout the body. “Because NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, leading to delayed detection and treatment,” the company says.