Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said.
The company said that the NDA is supported by positive data from the Phase 3 ORBIT-3 and ORBIT-4 studies.
In 2014, Aradigm received fast track designation for Pulmaquin for NCFBE as well as QIDP designation for the product.
In 2013, Grifols acquired a worldwide license for Linhaliq (then Pulmaquin), and Grifols trademarked the name “Linhaliq) in 2015.
Read the Aradigm press release.
