COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Amikacin Sulfate 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 Amikacin Sulfate as an orphan drug on 26 February 2015 for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.
The dose form of Amikacin Sulfate for this indication is suspension for inhalation.
The sponsor of Amikacin Sulfate is Novotech (Australia) Pty Limited.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
26 February 2015