US FDA Accepts Bronchitol New Drug Application for Review

2nd Aug 12

Release Date: 02/08/2012 12:00am

Pharmaceutical company Pharmaxis (ASX: PXS) is pleased to announce it has received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its cystic fibrosis product, Bronchitol®, has been accepted for standard review.

The FDA has assigned the Bronchitol application a Prescription Drug User Fee Act (PDUFA) goal date of 18 March, 2013.  If the application is approved, Pharmaxis anticipates Bronchitol could be available for US patients with cystic fibrosis in the second quarter of 2013.


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