LNTH

LNTH-2501 (Gallium 68 edotreotide)

FDA PDUFA Target Action Date · Lantheus Holdings, Inc.

Monday, June 29, 2026

19 days ago

pending

Drug Information

Drug Name: LNTH-2501 (Gallium 68 edotreotide) (CT.gov)
Application Type: NDA
Indication: PET imaging for neuroendocrine tumors (NETs)

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