COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF dexamethasone (ozurdex) 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 dexamethasone (Ozurdex) as an orphan drug on 12 April 2017 for the treatment of non-infectious uveitis affecting the posterior section of the eye.
The dose form of dexamethasone (Ozurdex) for this indication is intravitreal implant.
The sponsor of dexamethasone (Ozurdex) is Allergan Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
12 April 2017