Aradigm gets CRL for Linhaliq

Aradigm Corp. (NASDAQ:ARDM) said FDA issued a complete response letter (CRL) for Linhaliq liposomal ciprofloxacin (ARD-3150) to treat non-cystic fibrosis bronchiectasis in patients with chronic Pseudomonas aeruginosa lung infections. The company says it plans to resubmit the NDA “as soon as possible.”

Aradigm said FDA identified deficiencies in the application including clinical data, human factors validation and product quality. The agency is requesting a third-party verification of Phase III results, an additional Phase III trial and an additional human factors study...