DESIGNATION OF decitabine (DACOGEN) 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 decitabine (DACOGEN) as an orphan drug on the 16 October 2012 for the treatment of adult patients ≥65 years with newly diagnosed de novo or secondary acute myeloid leukaemia (AML).
The dose form of decitabine (DACOGEN) for this indication is Injection.
The sponsor of decitabine (DACOGEN) is Janssen – Cilag Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
16 October 2012