Approval Date: 11-Sep-2026
Applicant: Telix Pharmaceuticals (US) Inc.
Product: PIXCLARA (floretyrosine F 18) injection
Application: NDA 218592
Regulatory Pathway: 505(b)(2)
The U.S. Food and Drug Administration (USFDA) approved PIXCLARA (floretyrosine F 18) injection on 11-Sep-2026, submitted by Telix Pharmaceuticals (US) Inc. under NDA 218592.
PIXCLARA is approved for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related changes, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.
The FDA letter states that the application was submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The NDA was originally received on August 27, 2024, and the March 13, 2026 amendment constituted a complete response to the FDA’s April 25, 2025 action letter.
Key Regulatory Details
- Product: PIXCLARA (floretyrosine F 18) injection
- Active Ingredient: floretyrosine F 18
- NDA: 218592
- Applicant: Telix Pharmaceuticals (US) Inc.
- Approval Date: 11-Sep-2026
- Route/Use: PET imaging
- Approved Population: Adults and pediatric patients 1 month of age and older
- Indication: Differentiation of recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations
- Regulatory Pathway: 505(b)(2)
- Dating Period: 14 hours from the End of Synthesis (EOS) when stored at controlled room temperature (15°C–25°C)
The application was not referred to an FDA advisory committee, as the FDA determined that outside expertise was not necessary. The FDA letter also notes that the product has an orphan drug designation, making the pediatric assessment requirement inapplicable under PREA.
Regulatory Intelligence Takeaway:
The approval expands the use of PET imaging in the diagnostic evaluation of glioma by providing an imaging agent intended to help differentiate recurrent or progressive disease from treatment-related changes. The approval covers both adult and pediatric patients aged 1 month and older.
Reference: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218592Orig1s000ltr.pdfhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218592