Posted by Michael Wonder on 14 Apr 2021
TGA accepts Telix’s prostate cancer imaging product submission and commences priority evaluation process
14 April 2021 - Telix is pleased to announce that the TGA has accepted the Company’s submission for the registration of its prostate cancer imaging product Illuccix (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11 injection) and has now commenced the priority evaluation process.
Under the priority registration pathway, the TGA will evaluate Telix’s submission to register Illuccix on the Australian Register of Therapeutic Goods with a target timeframe of 150 working days and an indicative decision date (‘Milestone 7 date’) of 12 November 2021.
Together with regulatory submissions in Canada, the European Union and the United States, Illuccix presently has regulatory reviews in progress in 17 countries globally.
