COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF FEDRATINIB 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 Fedratinib as an orphan drug on 23 October 2013 for the treatment of primary myelofibrosis, of post-polycythaemia vera myelofibrosis and of post-essential thrombocythaemia myelofibrosis.
The dose form of Fedratinib for this indication is capsules.
The sponsor of Fedratinib is Sanofi-Aventis Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Office of Scientific Evaluation
Delegate of the Secretary
23 October 2013