US FDA Convenes Advisory Committee to Advise on Use of Bronchitol
Release Date: 26/03/2019 8:55am
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced the US Food and Drug Administration (FDA) will convene a Pulmonary-Allergy Drugs Advisory Committee (PADAC) on 8 May 2019 (US time) to make recommendations on the use of Bronchitol® for adult cystic fibrosis patients in the United States.
The Bronchitol New Drug Application was resubmitted to the FDA in December 2018 by Pharmaxis licensee, Chiesi Group (Chiesi) who are responsible for the regulatory approval process. Pharmaxis is supporting Chiesi in its preparations for the PADAC meeting.
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