DESIGNATION OF Ponatinib (tradename 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 Ponatinib (tradename TBA) as an orphan drug on 14 May 2013 for the treatment of acute lymphoblastic leukaemia and adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy.
The dose form of Ponatinib (tradename TBA) for this indication is 15 mg and 45 mg immediate film coated tablets.
The sponsor of Ponatinib (tradename TBA) is ARIAD Pharmaceutical (Australia) Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
14 May 2013