TLX

Pixclara (Floretyrosine F 18 or 18F-FET)

Name: Telix Pharmaceuticals Ltd FDA PDUFA Decision
Start: 2026-09-11

FDA PDUFA Target Action Date · Telix Pharmaceuticals Ltd

Friday, September 11, 2026

Approved

approved

Note: Approved 2026-09-11 as PIXCLARA (ORIG NDA218592). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.

Drug Information

Drug Name: Pixclara (Floretyrosine F 18 or 18F-FET) (CT.gov)
Application Type: NDA
FDA Designations: Orphan DrugFast Track
Indication: glioma (brain cancer)
Approved As: Pixclara (Floretyrosine F 18 or 18F-FET)

Filing Details

Company: Telix Pharmaceuticals Ltd →
Stock Ticker: TLX
SEC CIK: 0002007191
Source: SEC EDGAR (LLM-extracted from primary filing) →

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

Explore Telix Pharmaceuticals Ltd

View Telix Pharmaceuticals Ltd's full pipeline, approved drugs, and clinical trials.

View Pipeline → FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue