COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF denosumab (xgeva) 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 denosumab (XGEVA) as an orphan drug on 27 June 2014 for the treatment of hypercalacaemia of malignancy that is refractory to intravenous bisphosphonates.
The dose form of denosumab (XGEVA) for this indication is solution for injection.
The sponsor of denosumab (XGEVA) is Amgen Australia Pty Ltd.
(Signed By)
Dr Anthony Gill
Delegate of the Secretary
27 June 2014