Telix Pharmaceuticals has received notification that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmitted new drug application (NDA) for Pixclara (F-18 floretyrosine), a PET imaging agent for glioma.
The agent is designed to characterize recurrent or progressive glioma from treatment-related changes in both adult and pediatric patients, the company said. The FDA has granted Pixclara orphan drug and fast track designations, and the agent is already recommended in international clinical practice guidelines, according to Telix.
The company's PDUFA goal date is September 11, 2026.
