COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF OLAPARIB 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 Olaparib as an orphan drug on 15 January 2014 is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapse BRCA-mutated ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum-based chemotherapy.
The dose form of Olaparib for this indication is capsule.
The sponsor of Olaparib is AstraZeneca Pty Ltd.
(Signed by)
Dr Anthony Gill
Office of Scientific Evaluation
Delegate of the Secretary
15 January 2014