COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF arsenic trioxide 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 Arsenic Trioxide as an orphan drug on 16 March 2017 for the treatment of Acute Promyelocytic Leukaemia (APL).
The dose form of Arsenic Trioxide for this indication is capsule.
The sponsor of Arsenic Trioxide is Phebra Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
16 March 2017