COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Fomepizole (TBA) AS AN ORPHAN DRUG
I, Dr Anthony Gill, Delegate of the Secretary for the purposes of 16J of the Therapeutic Goods Regulations 1990 (“the Regulations”), acting under subregulation 16J(2) of the Regulations, designate Fomepizole (TBA) as an orphan drug on 6 January 2015 for the treatment of ethylene glycol and methanol poisonings.
The dose form of Fomepizole (TBA) for this indication is Injection.
The sponsor of Fomepizole (TBA) is AFT Pharmaceuticals Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
6 January 2015