Pharmacies will be able to order replacement EpiPen Jr stock as early as this week
The TGA says new stock of EpiPen Jr will be available to order as soon as this week.
An update issued earlier last Friday (13 December) said a new batch of the product “which is being conditionally released… is now in Australia”.
“The pens are now being labelled and packaged before being dispatched to wholesalers. They will be available for pharmacies to order from mid-next week (18 or 19 December 2019),” the TGA said.
Manufacturer Mylan was set to write to pharmacies to provide further information, including details on how to order the replacement products.
In an alert sent on 5 December, the TGA said it had been advised by Mylan that “stock of EpiPen Jr has run out in Australia. TGA is working with Mylan to confirm arrangements for supply of the new batch”.
Earlier that week, the TGA said as an emergency measure it would allow one batch of Epipen Jr to be supplied that “has not met all the required quality specifications.”
The conditional release applies to batch number 9KC652.
Several batches of Epipen Jr had been found to be affected by very low-level contamination with pralidoxime – used to treat people who have been poisoned by pest-control chemicals.
“This was caused by a manufacturing issue between production batches of different products,” the agency said. It added that the human safety profile of pralidoxime had been “well established”.
The TGA advised that it had been working closely with healthcare professional and consumer allergy groups on this shortage.
Advice for healthcare professionals, parents and carers about management during the shortage period is available on the following websites: Australasian Society of Clinical Immunology and Allergy (ASCIA) and Allergy and Anaphylaxis Australia.