COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Defactinib 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 Defactinib as an orphan drug on 24 November 2014 for the treatment of malignant mesothelioma.
The dose form of Defactinib for this indication is tablet
The sponsor of Defactinib is Plunkett Consulting Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
24 November 2014