NDA 218592, held by Telix. Floretyrosine F-18.
As of Nov 14, 2026, NDA 218592 (Pixclara), held by Telix, was first approved by FDA on Sep 11, 2026, with 0 approved supplements and 1 published complete response letter.
PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Apr 25, 2025 | NDA 218592Clinical/Statistical, Product Quality | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pixclara5-300mCi/ML · solution;intravenous | Floretyrosine F-18 | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
