FDA Provides Guidance on Bronchitol Approval Steps - FDA Expected to Complete Review Q2 2020
Release Date: 28/10/2019 9:20am
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Group (Chiesi) has received detailed advice from the US Food and Drug Administration (FDA) on its plan to fulfil the requirements necessary to approve Bronchitol® (mannitol) for the treatment of adult cystic fibrosis patients in the United States. Based on this feedback Chiesi has added an additional month to its timetable. The FDA review of the Bronchitol NDA is therefore now expected to be completed in the second quarter of 2020.
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