COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Riluzole (Teglutik) 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 Riluzole (Teglutik) as an orphan drug on 13 February 2017 for the treatment of patients with amyotrophic lateral sclerosis (ALS).
The dose form of Riluzole (Teglutik) for this indication is liquid - oral suspension.
The sponsor of Riluzole (Teglutik) is Seqirus Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
13 February 2017