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Approvals Action
New eye drug for diabetics

Posted 12 August 2019

Specialised Therapeutics has won Australian approval for diabetic macular oedema drug Iluvien.

The local business has commercialisation rights for the drug in Australia under an exclusive licence from its US owner Alimera Sciences.

A statement released by Alimera on approval of the drug quoted Carlo Montagner, CEO of Specialised Therapeutics as saying his company would now seek Iluvien reimbursement through the PBS.

The regulator has assigned the medicine a 'black triangle', used for "certain types of new prescription medicines, or those being used in significantly different ways". The scheme puts HCPs and patients on alert for adverse events so as to assist the TGA build up the medicine's safety profile.

Meanwhile, Accord Healthcare became the third company to copy Otsuka's Busulfex under brand names Busulfan Intas and Busulfan Accord. The therapies are used in combination with cyclophosphamide, melphalan or fludarabine in conditioning to haematopoietic stem cell transplantation.

Apotex and Aspen also have drugs registered, however no sponsors have their generic therapies listed on the PBS.

Both Neo Health and Nova Pharmaceuticals added pain relief medications, Neo Health anti-inflammatory pain relief liquid capsules and Coles Paracetamol, respectively.

Coles was recently shown to be consumers second choice of Supermarket to buy headache and pain relief medication.

NEW PRODUCTS
Product Sponsor ARTG Date Link
ILUVIEN fluocinolone acetonide 190 mcg intravitreal implant in applicator Specialised Therapeutics Alim  6/08/2019 306543
GENERICS YET TO BE PBS LISTED
Product Sponsor ARTG Date Link
BUSULFAN INTAS, BUSULFAN ACCORD busulfan 60 mg/10 mL concentrated injection vial Accord Healthcare 2/08/2019 300849
OTCs
Product Sponsor ARTG Date Link
NEO HEALTH ANTI-INFLAMMATORY PAIN RELIEF LIQUID CAPSULES naproxen sodium 275 mg soft capsule blister pack Neo Health (OTC) 1/08/2019 321191
COLES PARACETAMOL 500mg capsule shaped tablet blister pack (new formulation) Nova Pharmaceuticals 5/08/2019 321306

Tiffany Walker

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Approvals Action
New eye drug for diabetics
In-licensed second-line option for DME.