COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Pegaspargase (Oncaspar) 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 Pegaspargase (ONCASPAR) as an orphan drug on 24 April 2015 for the treatment of patients with acute lymphoblastic leukaemia (ALL).
The dose form of Pegaspargase (ONCASPAR) for this indication is solution for injection.
The sponsor of Pegaspargase (ONCASPAR) is Link Medical Products.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
24 April 2015