# TAUKLARIFY (florquinitau F 18; MK-6240) PDUFA Event: PET imaging to identify tau neurofibrillary tangle pathology in Alzheimer's disease evaluation

Canonical URL: https://biopharmsignal.com/pdufa-calendar/LNTH/mk-6240-alzheimers-disease

Ticker: LNTH

Company: Lantheus Holdings, Inc.

Event date: 2026-08-13

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-08-13

Application type: NDA

FDA approved TAUKLARIFY for tau PET imaging. FDA approved TAUKLARIFY (florquinitau F 18), previously known as MK-6240, for PET imaging of the brain in adults...

## Event Timeline

### August 13, 2026 — FDA approved TAUKLARIFY for tau PET imaging

FDA approved TAUKLARIFY (florquinitau F 18), previously known as MK-6240, for PET imaging of the brain in adults with cognitive impairment being evaluated for Alzheimer's disease to identify tau neurofibrillary tangle pathology. The approval was recorded under NDA 220496.

[FDA Drugs@FDA — TAUKLARIFY NDA 220496](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220496)

### October 28, 2025 — FDA accepted the MK-6240 NDA

FDA accepted the application for the F18-labeled tau PET imaging agent and assigned an August 13, 2026 action date.

[Lantheus — FDA acceptance of the MK-6240 NDA](https://investor.lantheus.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-new-drug-application-mk-6240)

### April 30, 2025 — Two pivotal studies met co-primary endpoints

MK-6240 met the co-primary sensitivity and specificity endpoints in two pivotal studies supporting the NDA.

[Lantheus — MK-6240 pivotal study results](https://investor.lantheus.com/news-releases/news-release-details/lantheus-announces-alzheimers-disease-radiodiagnostic-mk-6240)

## Regulatory Designations

- Fast Track FDA: [Lantheus — Fast Track status and NDA acceptance](https://investor.lantheus.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-new-drug-application-mk-6240)

## Related Pages

- LNTH PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/LNTH.md

- LNTH company profile: https://biopharmsignal.com/company/LNTH.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md