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 17 May 2016 for the treatment of the following:
- idiopathic pulmonary arterial hypertension,
- familial pulmonary arterial hypertension,
- pulmonary arterial hypertension associated with scleroderma, and
- pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger’s physiology,
in patients with WHO functional Class II, III or IV symptoms.
The dose form of Bosentan for this indication is film coated tablet.
The sponsor of Bosentan is Amneal Pharma Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
1 June 2016