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Indomethacin (Indocid PDA): anticipated shortage

13 January 2010

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.