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# FDA Nixes Aradigm NDA for Linhaliq
- URL: https://www.fdaweb.com/fda-nixes-aradigm-nda-for-linhaliq/
- Published: 2018-01-29T12:00:00.000Z
- Updated: 2026-09-14T23:17:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140620

FDA has issued Aradigm a complete response letter (CRL) on its NDA for Linhaliq (liposomal ciprofloxacin for inhalation) as a treatment for non-cystic fibrosis bronchiectasis patients with chronic *Pseudomonas aeruginosa* (*P. aeruginosa*) lung infections. The letter says the NDA cannot be approved in its present form, and provides recommendations needed for resubmission, according to the company. Areas of concern include clinical data, human factors validation study and product quality, it says.

“The recommendations in the CRL include an independent third party verification of the Phase 3 results via analyses of source data as per the statistical analysis plan and an additional Phase 3 clinical trial that demonstrates a significant treatment effect on clinically meaningful endpoints which could evaluate the co-primary endpoints of frequency and severity of exacerbations to assess for durable evidence of efficacy over a period of two years (or more, if scientifically justified),” Aradigm says. The CRL also requests that the company conduct another human factors study to demonstrate that product packaging and instructions for use are effective, it says. And it requests, among other things, additional microbiology data and a new *in vitro* drug release method development report.

Earlier this month, an FDA advisory committee vote 12 to 3 against recommending approval, citing inconsistent efficacy data and concern over the endpoint of pivotal trials. Panel members reportedly disagreed with the company’s primary endpoint selection (time to first pulmonary exacerbation), which some called a surrogate for what they believed to be a more appropriate endpoint — exacerbation frequency.