COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF tobramycin 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 tobramycin as an orphan drug on 10 February 2016 for the treatment of cystic fibrosis patients infected with Pseudomonas aeruginosa.
The dose form of tobramycin for this indication is solution for inhalation.
The sponsor of Tobramycin is Boucher & Muir Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
10 February 2016