Linhaliq NDA Granted Priority Review
The NDA is for the treatment of non-cystic fibrosis bronchiectasis patients with chronic infections with P. aeruginosa
Aradigm Corporation announced that their New Drug Application (NDA) for Linhaliq has been accepted for filing with Priority Review by the Food and Drug Administration (FDA).
The NDA is for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa). Linhaliq was previously granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track designation for NCFBE patients with lung infections with P. aeruginosa.
"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," said Dr. Igor Gonda, Aradigm CEO.
A Prescription Drug User Fee Act goal date of January 26, 2018 has been set for the completion of the FDA review.
For more information visit Aradigm.com.