COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Isavuconazonium sulfate 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 Isavuconazonium sulfate as an orphan drug on 17 December 2015 for the treatment of invasive aspergillosis and invasive mucormycosis in patients 18 years of age and older.
The dose forms of Isavuconazonium sulfate for these indications are powder for injection and hard capsules.
The sponsor of Isavuconazonium sulfate is JACE Pharma Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
17 December 2015