Lantheus Gets FDA PDUFA Date For LNTH-2501 Diagnostic Kit In March
(RTTNews) - Lantheus Holdings, Inc. (LNTH) said Thursday that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2026, for LNTH-2501.
LNTH-2501 is a diagnostic kit used to prepare Ga 68 edotreotide injection, indicated for use with positron positron emission tomography (PET) imaging to localize somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients.
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