DESIGNATION OF Cholic Acid (TBA) 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 (TBA)as an orphan drug on 22nd July 2013 for the treatment of inborn errors of bile acid synthesis responsive to treatment with cholic acid.
The dose form of Cholic Acid (TBA) for this indication is oral capsules 50 mg and 250 mg.
The sponsor of Cholic Acid (TBA) is Orpharma Pty Ltd.
(signed by)
Dr Anthony Gill
Delegate of the Secretary
23rd July 2013