Posted by Michael Wonder on 26 Sep 2017
Aradigm announces FDA acceptance of NDA for Linhaliq with priority review status
25 September 2017 - Aradigm today announced that the U.S. FDA has accepted for filing with priority review its new drug application for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic infections with Pseudomonas aeruginosa.
The granting of priority review for the Linhaliq application accelerates the timing of the FDA review of the application compared to a standard review.
The PDUFA goal date for completion of the FDA review of the Linhaliq application is 26 January 2018.
