DESIGNATION OF Pomalidomide 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 Pomalidomide as an orphan drug on the 17 October 2012 for the treatment of multiple myeloma in patients who have failed two or more prior therapies.
The dose form of Pomalidomide for this indication is capsules.
The sponsor of Pomalidomide is Celgene Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
17 October 2012