DESIGNATION OF Ibuprofen (PEDEA) 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 Ibuprofen (PEDEA) as an orphan drug on 22nd May 2013 for the treatment of haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
The dose form of Ibuprofen (PEDEA) for this indication is solution for injection.
The sponsor of Ibuprofen (PEDEA) is Emerge Health Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
22 May 2013