COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Mercaptamine Hydrochloride (CYSTADROPS) 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 Mercaptamine Hydrochloride (CYSTADROPS) as an orphan drug on 17 July 2015 for the treatment of corneal cystine deposits in cystinosis in adults and children over two years of age.
The dose form of Mercaptamine Hydrochloride (CYSTADROPS) for this indication is eye drops solution.
The sponsor of Mercaptamine Hydrochloride (CYSTADROPS) is Emerge Health Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
17 July 2015