Posted on Sunday, 27th December 2009 by admin
Shares in biotechnology company Pharmaxis dropped 6 per cent this morning after the US Food and Drug Administration (FDA) knocked back a new drug application for its asthma diagnosis product, Aridol.
In a letter sent to Pharmaxis by the FDA, the government regulator said it had observed deficiencies at three subcontracting manufacturing facilities.
Pharmaxis chief executive Alan Robertson said the letter and comments from the FDA provided a clear outline of the regulator’s requirements.
He said Pharmaxis would work with the FDA to meet the matters raised in their response.
In midday trade, Pharmaxis shares were 16 cents lower, or 5.5 per cent, at $2.73.
Aridol is a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness.
Patients inhale Aridol via a hand-held device, allowing doctors to determine the severity of a patient’s inflammation and prescribe the right amount of medication to bring it under control.
Aridol is approved for sale in Australia, major European countries and Korea.
egreenblat@theage.com.au
The Age
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Tags: Fda, Fda Rebuff
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