DESIGNATION OF recombinant factor IX (FIXTERA) 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 recombinant factor IX (FIXTERA) as an orphan drug on the 3rd October 2012 for the treatment of the control and prevention of haemorrhagic episodes and for routine and surgical prophylaxis in patients with haemophilia B (congenital factor IX deficiency or Christmas disease).
The dose form of recombinant factor IX (FIXTERA) for this indication is IV injection.
The sponsor of recombinant factor IX (FIXTERA) is Baxter Healthcare Pty Ltd.
(signed by)
Dr Anthony Gill
Delegate of the Secretary
3rd October 2012