Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)
Lantheus Holdings announced that the FDA has issued a Complete Response Letter for the New Drug Application of LNTH-2501 (Ga 68 edotreotide), a PET diagnostic imaging agent for neuroendocrine tumors. The FDA's decision is due to unresolved manufacturing facility conditions unrelated to the drug's clinical data, safety, or efficacy. Lantheus is work…