Posted by Michael Wonder on 28 Jun 2026
Lantheus receives complete response letter from FDA for LNTH-2501 (Ga 68 edotreotide)
26 June 2026 - Lantheus Holdings announced today that the US FDA has issued a complete response letter regarding its new drug application for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor positive neuroendocrine tumors.
The FDA stated that the agency cannot approve the new drug application by the PDUFA action date of 29 June 2026, due to unresolved third-party facility manufacturing related conditions.
