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Home » Aradigm Receives CRL for Linhaliq, Citing Quality and Data Concerns
Aradigm Receives CRL for Linhaliq, Citing Quality and Data Concerns
The FDA issued a complete response letter to Aradigm over its Linhaliq (ciprofloxacin liposomal) submission for non-cystic fibrosis bronchiectasis, a severe, rare lung disease frequently associated with chronic lung infections, saying the drug could not be approved in its current form.