Pharmaxis Receives Complete Response Letter from FDA on Bronchitol
Release Date: 19/03/2013 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) today announced it had received a complete response letter from the Food and Drug Administration (FDA) confirming Bronchitol® cannot yet be approved for marketing for the treatment of cystic fibrosis in the United States.
The FDA has concluded its review of the Bronchitol New Drug Application (NDA) and recommended Pharmaxis conduct an additional clinical trial to obtain an approval for Bronchitol.
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