COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF BOSENTAN 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 Bosentan as an orphan drug on 2 December 2014 for the treatment of Pulmonary Arterial Hypertension.
The dose form of Bosentan for this indication is film coated tablet.
The sponsor of Bosentan is Actelion Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
2 December 2014