COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF nitric oxide (INOmax) 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 nitric oxide (INOmax) as an orphan drug on 11 September 2013 that is indicated, in conjunction with ventilator support and other appropriate agents, as part of the treatment of peri-and post-operative pulmonary hypertension in newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction with heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
The dose form of nitric oxide (INOmax) for this indication is inhalational gas.
The sponsor of nitric oxide (INOmax) is Ikaria Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Office of Scientific Evaluation
Delegate of the Secretary
12 September 2013