COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Chenodeoxycholic acid 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 Chenodeoxycholic acid as an orphan drug on 24 February 2016 for the treatment of inborn errors of primary bile acid synthesis.
The dose form of Chenodeoxycholic acid for this indication is capsule.
The sponsor of Chenodeoxycholic acid is Link Healthcare Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
24 February 2016