COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF idebenone (Raxone) 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 idebenone (Raxone) as an orphan drug on 27 February 2017 for the treatment of Duchenne muscular dystrophy (DMD).
The dose form of idebenone (Raxone) for this indication is tablet, film-coated.
The sponsor of idebenone (Raxone) is Jace Pharma Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
27 February 2017