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Aradigm submits MAA for Linhaliq for non-cystic fibrosis bronchiectasis patients.

Aradigm announced it has submitted its marketing authorisation application, or MAA to European Medicines Agency, or EMA, for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infection with pseudomonas aeruginosa. In accordance with article 8 and Annex I, Part II.7 of Directive 2001/83/EC, Aradigm is submitting a mixed MAA for Linhaliq that is based on the positive Phase 3 pivotal clinical trial ARD-3150-1202 and supporting evidence from Phase 3 study ARD-3150-1201 and Phase 2b study ARD-3150-0902, together with other supporting evidence from proprietary preclinical and clinical studies, as well as referencing additional information about ciprofloxacin from publicly available sources. The EMA has a 21-day validation review period to determine whether the MAA is complete before starting the procedure.

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Publication:The Fly
Date:Mar 9, 2018
Words:125
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