COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Cholic acid (ORPHACOL) 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 Cholic acid (ORPHACOL) as an orphan drug on 4 September 2014 for the treatment of inborn errors of primary bile acid synthesis due to 3β-hydroxy-Δ5-C27-steroid oxidoreductase (3β-HSD) deficiency or Δ4-3-oxosteroid 5β-reductase (Δ4-3-oxoR) deficiency.
The dose form of Cholic acid (ORPHACOL) for this indication is capsule.
The sponsor of Cholic acid (ORPHACOL) is Emerge Health.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
3 October 2014