The TGA is aware of an expected, temporary shortage of supplies of injectable indomethacin (trade name INDOCID PDA) in Australia from February 2010. The shortage has arisen as a result of a change in manufacturing site in the USA.
Indocid PDA is used to treat patent ductus arteriosus, a potentially serious but uncommon condition in newborn babies.
The TGA is working closely with the sponsor Pharmalink to resolve this problem and to minimise the impact on patients.
An alternative injectable medication, ibuprofen lysine, is available overseas for the treatment of this condition.
Neonatologists are advised that they may submit Category A notifications under the Special Access Scheme (SAS) if they wish to use this alternative medication.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.