NDA

February 28, 2019February 28, 2019

FDA Maintains Refusal of Aradigm’s Bronchiectasis Bacteria Therapy and Recommends Further Study

News

The U.S. Food and Drug Administration (FDA) has stood by its initial refusal to approve Apulmiq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) associated with chronic Pseudomonas aeruginosa lung infection. The agency recommended ... Read more

January 30, 2018January 30, 2018

Aradigm’s Linhaliq NDA for Non-CF Bronchiectasis Fails to Get FDA Approval

News

The U.S. Food and Drug Administration (FDA) told Aradigm the agency could not approve the company’s New Drug Application (NDA) for Linhaliq in its present form. Linhaliq is designed to treat patients with non-cystic ... Read more

September 26, 2017September 26, 2017

FDA Accepts Aradigm’s New Drug Application for Linhaliq to Treat Non-CF Bronchiectasis

News

A new drug application (NDA) submitted by Aradigm for Linhaliq (inhaled ciprofloxacin) was recently accepted for filing with priority review status by the U.S. Food and Drug Administration (FDA). The NDA ... Read more

May 16, 2017May 16, 2017

Aradigm Advances Development of Linhaliq (Formerly Pulmaquin) for Non-CF Bronchiectasis

News

Aradigm discussed data from Phase 3 trials assessing the company’s inhaled form of ciprofloxacin, called Linhaliq (formerly known as Pulmaquin), with the U.S. Food and Drug Administration (FDA) to advance the drug’s development and obtain marketing ... Read more