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# Aradigm Files NDA for Pulmonary Drug Linhaliq
- URL: https://www.fdaweb.com/aradigm-files-nda-for-pulmonary-drug-linhaliq/
- Published: 2017-07-27T12:00:00.000Z
- Updated: 2026-09-14T22:36:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139238

Aradigm has submitted an NDA for Linhaliq (liposomal ciprofloxacin for inhalation) for treating non-cystic fibrosis bronchiectasis patients with chronic lung infections with *Pseudomonas aeruginosa*. The submission is based on data from the Phase 3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and confirmatory evidence from the Phase 3 study ARD-3150-1201 (ORBIT-3).

  
In ORBIT-4 the median time to first pulmonary exacerbation was 230 days in the Linhaliq treatment group as compared to 158 days in the placebo group. In ORBIT-3 the median time to first pulmonary exacerbation was 214 days in the Linhaliq treatment group as compared to 136 days in the placebo group.