COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Inotuzumab ozogamicin (besponsa) 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 Inotuzumab Ozogamicin (BESPONSA) as an orphan drug on 19 December 2016 for the treatment of B-cell acute lymphoblastic leukaemia (ALL).
The dose form of Inotuzumab Ozogamicin (BESPONSA) for this indication is powder for injection.
The sponsor of Inotuzumab Ozogamicin (BESPONSA) is Pfizer Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
9 January 2017