ASX News

NDA Clinical Briefing Package Submitted to the US FDA

Melbourne (Australia) – 27 Dec 2019. Telix Pharmaceuticals announces that it has submitted a complete clinical briefing package to the US FDA for its first product TLX591-CDx1

Telix Pharmaceuticals Limited is pleased to announce that it has submitted a complete clinical briefing package to the US FDA for its first product TLX591-CDx1, following the procedural guidance received from its pre-NDA2 meeting (reported 28th August 2019).

Telix has also completed the additional manufacturing and product release analytics that were recommended by the FDA. Consequently, the amended Drug Master File (DMF) will be filed with the FDA during January 2020 as part of the company’s ongoing NDA submission process.

To read the full media release please click here.