FDA rejects Lantheus drug application over manufacturing issues
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Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)
June 26, 2026 4:01 PM EDTBEDFORD, Mass., June 26, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus or Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).Â
The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due... More
