Aridol FDA Import Restrictions
Release Date: 03/06/2013 12:00am
Pharmaceutical company Pharmaxis (ASX:PXS) advises that the US Food and Drug Administration (FDA) has included Aridol® on an Import Alert list which has the effect of stopping the import of Aridol into the US until such time as it is removed from the list.
Pharmaxis has not received any direct communication from the FDA in relation to the listing and is seeking to clarify the reasons for the listing with the FDA. The Company believes the listing may relate to issues outstanding from a 2012 scheduled FDA audit of a third party contract packer. Pharmaxis continues to work with the packer in its response to the audit findings in order to have Aridol removed from the Import Alert as soon as possible.
Sales of Aridol in the US averaged $33,000 per month for the March quarter. Pharmaxis has approximately three months of inventory in the US.
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