Thursday, August 13, 2026
Approved
approved Note: Approved 2026-08-13 as TAUKLARIFY (florquinitau F 18 injection; NDA220496 in drugs.json), announced 2026-08-14. Not auto-resolved: the entry uses only the code MK-6240. Source: https://www.globenewswire.com/news-release/2026/08/14/3345281/0/en/lantheus-announces-fda-approval-of-tauklarify-florquinitau-f-18-injection-an-f18-labeled-tau-pet-imaging-agent-for-alzheimer-s-disease.html
Drug Information
- Drug Name
- MK-6240 (CT.gov)
- Application Type
- NDA
- FDA Designations
- Fast Track
- Indication
- PET imaging for detection of tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer's disease
- Approved As
- MK-6240
Filing Details
- Company
- Lantheus Holdings, Inc. →
- Stock Ticker
- LNTH
- Source
- Company IR →
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: 2026-08-02. Report an issue