Note: CRL explicitly confirmed by the company's own IR newsroom release, dated June 26, 2026 (three days before the June 29, 2026 PDUFA date) — I opened the Lantheus IR page directly and it states the FDA issued a Complete Response Letter for the LNTH-2501 NDA. This is NOT an inference from absence of approval. FDA acted 2026-06-26 (target was 2026-06-29). Source: https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-complete-response-letter-fda-lnth-2501-ga-68
Drug Information
- Application Type
- NDA
- Indication
- PET imaging for neuroendocrine tumors (NETs)
- Approved As
- LNTH-2501 (Gallium 68 edotreotide)
Filing Details
- Company
- Lantheus Holdings, Inc. →
- Stock Ticker
- LNTH
- SEC CIK
- 0001521036
- Source
- GlobeNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue