Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)

▤ Summary

Lantheus received a Complete Response Letter from the FDA for LNTH-2501, its gallium 68 edotreotide diagnostic imaging kit. The FDA said it cannot approve the NDA on the current timeline because of unresolved manufacturing conditions at a third-party facility. Lantheus said the letter did not raise concerns about the submitted data or the product’s safety and efficacy. The company is working with its manufacturing partner and the FDA to resolve the facility issues and move the program forward.

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