COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF PANOBINOSTAT (FARYDAK) 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 Panobinostat (FARYDAK) as an orphan drug on 21 January 2014 for the treatment of patients with relapsed multiple myeloma (MM), or relapsed-and-refractory MM.
The dose form of Panobinostat (FARYDAK) for this indication is capsules.
The sponsor of Panobinostat (FARYDAK) is Novartis Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
12 February 2014