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Production problems hamper Lantheus bid for FDA approval of LNTH-2501 radiopharma diagnostic kit

on July 05, 2026

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Lantheus received a Complete Response Letter (CRL) from the FDA for its radiopharmaceutical diagnostic kit LNTH-2501 (Gallium 68 edotreotide) due to unresolved manufacturing issues at a third-party facility; the FDA did not raise concerns about the clinical data, safety, or efficacy of the product; the company is working with the CDMO and the FDA to resolve the facility-related conditions so the NDA can be approved.

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CDMO Complete Response Letter diagnostic kit Edotreotide gallium IL31RA gene Lantheus LNTH-2501 manufacturing issues Radiopharmaceuticals third-party facility United States Food and Drug Administration

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