Fludarabine Phosphate Injection Section 19A Approval – Now Available from Pro Pharmaceuticals Group
Updated: Sep 1
Historical supply notice: This article relates to a previous medicine shortage or regulatory approval. Availability and regulatory status may have changed. Healthcare professionals should contact Pro Pharmaceuticals Group to confirm the current supply position.
For current Australian shortage and supply information, see medicine shortages in Australia.
Please note the UK-sourced alternative now in effect supersedes the USA-sourced (Areva) product described below.
Update – PBS listing effective 1 January
Fludarabine phosphate injection has now been formally listed on the Pharmaceutical Benefits Scheme (PBS) effective 1 January.
This PBS listing supports access to fludarabine for eligible patients, including use in appropriate hospital-managed and outpatient oncology settings.
PBS items: 15144C, 15145D
Further details are available on the PBS website:https://www.pbs.gov.au/medicine/item/15144C-15145D
Pro Pharmaceuticals Group continues to support supply of Fludarabine Phosphate Injection, USP (Areva, USA) in Australia under the TGA Section 19A pathway.
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Dear Healthcare Professional,
Pro Pharmaceuticals Group wishes to advise that the Australian registered product FLUDARABINE JUNO (fludarabine phosphate 50 mg powder for injection vial, AUST R: 147831) is currently in shortage, as listed on the TGA Medicines Shortage Database.
To ensure continuity of care, the TGA has granted approval under Section 19A of the Therapeutic Goods Act 1989 for supply of an alternative product:
Fludarabine Phosphate Injection, USP 50 mg/2 mL (25 mg/mL) Single-Dose Vial (Areva, USA)
This product is registered and marketed in the United States and is approved for import and supply in Australia until 31 August 2026, specifically for the treatment of B-cell chronic lymphocytic leukaemia.
Key Details
Equivalent active ingredient and strength to the Australian product
Ready-to-use sterile solution (no reconstitution required)
Supplied as a single-dose vial
Storage: Refrigerated at 2–8°C
Labelled in English
We encourage hospital pharmacies and oncology units to circulate this information internally and contact us regarding supply.
📧 Orders & Enquiries: orders@propg.com.au📞 Phone: 1300 077 674🌐 Website: www.propg.com.au
