On Friday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Lantheus Holdings Inc.’s (NASDAQ:LNTH) New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors.
FDA Issues Complete Response Letter For Lantheus Imaging Agent
The FDA stated unresolved third-party facility manufacturing-related conditions.
The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.
The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.
