USFDAJun 26, 2026, 04:02 PM
Lantheus Receives FDA Complete Response Letter for LNTH-2501 NDA
AI Summary
Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for LNTH-2501. The CRL was due to unresolved third-party facility manufacturing-related conditions and not related to the clinical performance, safety, or efficacy data of the product. Lantheus stated it is working closely with its partner and the FDA to resolve these issues to advance the program.
Key Highlights
- FDA issued a Complete Response Letter (CRL) for LNTH-2501 (Gallium 68 edotreotide) NDA.
- CRL is due to unresolved third-party facility manufacturing-related conditions.
- The third-party facility is responsible for drug product manufacturing.
- No concerns were identified regarding the data, safety, or efficacy of LNTH-2501.
- Lantheus is working with its partner and the FDA to address the manufacturing conditions.
- The PDUFA action date was June 29, 2026.
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