Telix Update on FDA New Drug Application Review for Illuccix®
Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 17 June 2021. Telix announces participation in a late-cycle meeting with the U.S. FDA regarding the ongoing review of the NDA for its prostate cancer imaging investigational product Illuccix®.
Telix is pleased to announce that the Company has participated in a late-cycle meeting with the U.S. Food and Drug Administration (FDA, the Agency) regarding the ongoing review of the New Drug Application (NDA) for its prostate cancer imaging investigational product Illuccix® (Kit for the preparation of 68Ga-PSMA-11 injection). During the meeting, the FDA indicated that there are no outstanding substantive review issues with Telix’s submission.
Telix Chief Executive Officer, Dr. Christian Behrenbruch stated, “The late-cycle review meeting with the FDA continued a series of productive meetings with the Agency and sets the stage for the concluding phase of the NDA review process, including alignment on the final Illuccix® product label. We remain optimistic about a positive outcome and, accordingly, are working closely with our commercial partners to prepare for the U.S. launch of Telix’s lead product for prostate cancer imaging, pending approval. Delivering patient access to this important technology to support the management of prostate cancer remains a major corporate objective for Telix.”
Together with regulatory submissions in Australia, Canada, and Europe, Illuccix® presently has regulatory reviews in progress in 17 countries globally.
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