Approved overseas, not yet PBS-listed

Medicines that have an FDA approval on record but do not yet appear anywhere on the Australian Pharmaceutical Benefits Scheme. Being on this list is a factual data comparison, not a judgement — a medicine may be TGA-approved, available privately, or not sought for PBS listing at all.

53 FDA-approved medicines in Voxsanity's dataset have at least one active ingredient that does not appear anywhere on the current PBS Schedule.

Matched by active ingredient, not by product name: the FDA writes “carbidopa and levodopa” where the PBS writes “levodopa + carbidopa”, and salt and dosage-form wording differs on both sides. A further 3 medicines are left off this list because every ingredient is subsidised, just not together as that exact product. Where the two registries use different international names for the same substance, a medicine can still appear here in error, so this count may overstate slightly. It is a data comparison, never a statement that a medicine is unavailable — check with your doctor or pharmacist.

• ISATUXIMAB-IRFC FDA 2026-07-09 · not yet PBS-listed
• RIFAPENTINE FDA 2026-06-23 · not yet PBS-listed
• PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH FDA 2025-09-19 · not yet PBS-listed
• DEFLAZACORT FDA 2025-08-11 · not yet PBS-listed
• SEPIAPTERIN FDA 2025-07-28 · not yet PBS-listed
• DEHYDRATED ALCOHOL FDA 2025-07-09 · not yet PBS-listed
• CONCIZUMAB FDA 2024-12-20 · not yet PBS-listed
• CLOMIPHENE CITRTAE FDA 2024-11-08 · not yet PBS-listed
• NELARABINE FDA 2024-08-01 · not yet PBS-listed
• GIVINOSTAT FDA 2024-03-21 · not yet PBS-listed
• RESMETIROM FDA 2024-03-14 · not yet PBS-listed
• TOFERSEN FDA 2023-04-25 · not yet PBS-listed
• DOXEPIN HYDROCHLORIDE FDA 2023-04-03 · not yet PBS-listed
• RAMELTEON FDA 2022-08-24 · not yet PBS-listed
• LEVOCARNITINE ORAL FDA 2021-11-10 · not yet PBS-listed
• SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE FDA 2021-03-02 · not yet PBS-listed
• AMPHETAMINE SULFATE FDA 2021-01-22 · not yet PBS-listed
• VILTOLARSEN FDA 2020-08-12 · not yet PBS-listed
• PERPHENAZINE FDA 2020-04-06 · not yet PBS-listed
• GOLODIRSEN FDA 2019-12-12 · not yet PBS-listed
• TENAPANOR HYDROCHLORIDE FDA 2019-09-12 · not yet PBS-listed
• PRETOMANID FDA 2019-08-14 · not yet PBS-listed
• OMEGA-3-ACID ETHYL ESTERS FDA 2019-02-25 · not yet PBS-listed
• TETRACYCLINE HYDROCHLORIDE FDA 2018-11-07 · not yet PBS-listed
• ALCOHOL FDA 2018-06-21 · not yet PBS-listed
• PEGVALIASE-PQPZ FDA 2018-05-24 · not yet PBS-listed
• ADENOSINE FDA 2018-02-16 · not yet PBS-listed
• DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE FDA 2017-12-28 · not yet PBS-listed
• LORAZEPAM FDA 2017-12-22 · not yet PBS-listed
• DEXMETHYLPHENIDATE HYDROCHLORIDE FDA 2016-11-30 · not yet PBS-listed
• ETEPLIRSEN FDA 2016-09-19 · not yet PBS-listed
• ELBASVIR AND GRAZOPREVIR FDA 2016-01-28 · not yet PBS-listed
• IXAZOMIB FDA 2015-11-20 · not yet PBS-listed
• LEDIPASVIR AND SOFOSBUVIR FDA 2014-10-10 · not yet PBS-listed
• ESZOPICLONE FDA 2014-04-15 · not yet PBS-listed
• METRELEPTIN FDA 2014-02-24 · not yet PBS-listed
• BEDAQUILINE FUMARATE FDA 2012-12-28 · not yet PBS-listed
• LINACLOTIDE FDA 2012-08-30 · not yet PBS-listed
• DIETHYLPROPION HYDROCHLORIDE FDA 2011-10-24 · not yet PBS-listed
• DIVALPROEX SODIUM FDA 2011-04-21 · not yet PBS-listed
• ROPINIROLE FDA 2010-02-25 · not yet PBS-listed
• PHENDIMETRAZINE TARTRATE FDA 2008-01-28 · not yet PBS-listed
• LUBIPROSTONE FDA 2006-01-31 · not yet PBS-listed
• DEXRAZOXANE FDA 2004-09-28 · not yet PBS-listed
• ETODOLAC FDA 2002-12-03 · not yet PBS-listed
• TAZAROTENE FDA 2000-09-29 · not yet PBS-listed
• ALOSETRON HYDROCHLORIDE FDA 2000-02-09 · not yet PBS-listed
• DACARBAZINE FDA 1998-08-27 · not yet PBS-listed
• PHENTERMINE HYDROCHLORIDE FDA 1997-06-19 · not yet PBS-listed
• CHOLESTYRAMINE LIGHT FDA 1996-08-15 · not yet PBS-listed
• CIMETIDINE FDA 1994-05-17 · not yet PBS-listed
• METHAZOLAMIDE FDA 1993-06-30 · not yet PBS-listed
• METHOCARBAMOL FDA 1979-10-29 · not yet PBS-listed

Not medical advice. A medicine's absence from the PBS does not mean it is unavailable in Australia. Verify current availability and subsidised status with your doctor or pharmacist.

Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.