COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF para-aminosalicylic acid (PASER), 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 para-aminosalicylic acid (PASER), as an orphan drug on 11 February 2015 which is indicated for use as part of an appropriate combination therapy for the treatment of multi-drug resistant tuberculosis.
The dose form of para-aminosalicylic acid (PASER) for this indication is enteric coated granules.
The sponsor of para-aminosalicylic acid (PASER), is Link Medical Products Pty Limited
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
11 February 2015