TLX

Pixclara (Floretyrosine F 18 or 18F-FET)

FDA PDUFA Target Action Date · Telix Pharmaceuticals Ltd

Friday, September 11, 2026

55 days away

Drug Information

Drug Name: Pixclara (Floretyrosine F 18 or 18F-FET) (CT.gov)
Application Type: NDA
Indication: glioma (brain cancer)

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

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

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