Lantheus announces FDA established PDUFA date for LNTH-2501

Lantheus (LNTH) announced that the U.S. Food and Drug Administration, FDA, has established a Prescription Drug User Fee Act, PDUFA, date for LNTH-2501. LNTH-2501 is 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 in adult and pediatric patients. The FDA has set a PDUFA target action date of March 29, 2026.