According to Aradigm Corporation, the FDA has accepted its NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients for priority review. The agency set a PDUFA date of January 26, 2018.
Aradigm announced its submission of the NDA in July 2017.
Linhaliq (formerly Pulmaquin) has received orphan drug designation for the treatment of bronchiectasis and QIDP and Fast Track designations for the treatment of chronic P. aeruginosa infections in NCFBE.
Aradigm CEO Igor Gonda said, “We are pleased with the FDA’s acceptance of our NDA filing with priority review. We look forward to working with the FDA during the review process to support approval of Linhaliq and provide a much needed treatment for NCFBE patients with chronic lung infection with P. aeruginosa.”
Read the Aradigm press release.
