COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF sodium phenylbutrate (PHEBURANE) 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 sodium phenylbutrate (PHEBURANE) as an orphan drug on 13 August 2014 for the treatment of urea cycle disorders.
The dose form of sodium phenylbutrate (PHEBURANE) for this indication is granules.
The sponsor of sodium phenylbutrate (PHEBURANE) is Orpharma Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
13 August 2014