Pathway to US Approval Clarified After FDA Issues Complete Response Letter on Use of Bronchitol for Adult CF Patients - NDA Expected to be Completed Q1 2020
Release Date: 20/06/2019 8:41am
Pharmaceutical company Pharmaxis (ASX: PXS) today announced its US licensee Chiesi Group (Chiesi) has received a complete response letter from the US Food and Drug Administration (FDA) detailing the remaining matters to be addressed before Bronchitol® can be approved for adult cystic fibrosis (CF) patients in the United States. Based upon the clear and achievable path to approval communicated in the FDA complete response letter, Pharmaxis believes that the FDA review of the Bronchitol NDA will be completed in Q1 2020.
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