Aradigm announced that the Food and Drug Administration (FDA) has granted Fast Track status to Pulmaquin for the treatment of patients with non-cystic fibrosis bronchiectasis (non-CF BE) who develop chronic lung infections with Pseudomonas aeruginosa.
Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. It is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of non-cystic fibrosis bronchiectasis.
Earlier this year, the FDA designated Pulmaquin as a Qualified Infectious Disease Product (QDIP).
For more information visit Aradigm.com.