COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Ataluren (TRANSLARNA) 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 Ataluren (TRANSLARNA) as an orphan drug on 17 July 2015 for the treatment of patients with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene.
The dose form of Ataluren (TRANSLARNA) for this indication is granules.
The sponsor of Ataluren (TRANSLARNA) is Link Medical Products Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
17 July 2015.