COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Sodium Benzoate (Prohippur) 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 Benzoate (Prohippur) as an orphan drug on 6 December 2016 for the treatment of:
- Nonketotic hyperglycinaemia (NKH)
The dose form of Sodium Benzoate (Prohippur) for this indication is granules.
The sponsor of Sodium Benzoate (Prohippur) is Orpharma Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
6 December 2016