Printer Friendly

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.

COPYRIGHT 2018 The Fly
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2018 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:The Fly
Date:Mar 9, 2018
Previous Article:DropCar announces $6M private placement.
Next Article:U.S. employment preview:.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters