FDA Fast Tracks Pulmaquin for Chronic Lung Infections
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.