Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Key Inclusion Criteria: * Male or female study subjects must be adults (≥ 6 years of age) * Confirmed diagnosis of CF * History of chronic infection with P.aeruginosa * FEV1 ≥40% of predicted at Screening * Ability to comply with study medication use, study visits and procedures * Ability to produce 0.5 grams of sputum Key Exclusion Criteria: * Administration of any investigational drug within 8 weeks to Study Day 1 * Emergency room visit or hospitalization for CF or respiratory-related illness within 4 weeks prior to screening * History of alcohol, medication or illicit drug abuse within 1 yr. to screening * History of lung transplantation * Female of childbearing potential who are not practicing an acceptable method of birth control or who are lactating * Positive Pregnancy test * Use of any anti-pseudomonal antibiotics within 28 days prior to Study Day 1 * Initiation of chronic therapy within 28 days prior to Study Day 1 * History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years prior to screening * History of mycobacterial and/or Aspergillus infection requiring treatment within 2 years prior to screening * History of biliary cirrhosis with portal hypertension, or splenomegaly