Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)
Lantheus received a Complete Response Letter from the FDA for its NDA regarding LNTH-2501, delaying potential approval beyond the PDUFA target date of June 29, 2026. The agency cited unresolved manufacturing-related conditions at a third-party facility, specifically noting no concerns regarding the safety or efficacy data submitted by Lantheus.
Key figures
- Drug Name
- LNTH-2501 (Ga 68 edotreotide)
- Pdufa date
- June 29, 2026
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