Aradigm Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa). The granting of Priority Review for the Linhaliq NDA accelerates the timing of the FDA review of the application compared to a standard review. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Linhaliq NDA is January 26, 2018. Aradigm received Orphan Drug Designation for liposomal ciprofloxacin for inhalation for the management of bronchiectasis and for Linhaliq for the management of bronchiectasis. Additionally, for Linhaliq, Aradigm was granted Qualified Infectious Disease Product (QIDP) Designation for the treatment of NCFBE patients with chronic lung infections with P. aeruginosa followed by Fast Track Designation. Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. NCFBE patients who have chronic infections with P. aeruginosa have a 6.5-fold increase in hospitalization, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections. There is currently no drug approved for the treatment of this condition.