> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Telix NDA for PSMA-PET Imaging Kit
- URL: https://www.fdaweb.com/telix-nda-for-psma-pet-imaging-kit/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157427

FDA has accepted for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer. The agency has set a user fee review action target date of 3/24/2025.

“If approved, the new kit will enable use of a PSMA imaging product with a considerably extended geographic distribution radius from a nuclear pharmacy compared to currently approved gallium-68 (68Ga)-based agents,” the company says. “Its innovative properties are designed to facilitate more flexible production, including with higher activity 68Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab solid and liquid target production systems.”

Telix says its NDA submission is intended to provide more patients access to PSMA-PET imaging and the clinical benefits of 68Ga imaging to underserved populations across the U.S. under the company’s established nuclear pharmacy distribution partnerships.