Aradigm Corporation announces that the Antimicrobial Drugs Advisory Committee (ADAC) of the US Food and Drug Administration (FDA) did not recommend approval for Linhaliq™ as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections. The FDA has set a PDUFA action date of January 26, 2018 for the completion of its review of Linhaliq. The clinical program for Linhaliq was developed with guidance from the FDA, who also granted Orphan Drug (June 2011), Qualified Infections Disease Product (June 2014), and Fast Track (August 2014) designations to Linhaliq. The Linhaliq application was based on data from three clinical studies. Two Phase 3 studies, ORBIT-3 and ORBIT-4, were identically designed, multinational, randomized (2:1), double-blind and placebo controlled trials. Both were conducted concurrently in similar geographies over 48 weeks, with an additional 4 weeks of open-label treatment and a 30-day safety follow up. Together with the Phase 2b ORBIT-2 study, these trials provide evidence of the clinical benefit of Linhaliq for patients with NCFBE who have chronic lung infections with P. aeruginosa.