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Aztreonam for inhalation solution, challenges to drug approval and integration into CF care

Authors :
Scott C. Bell
Christopher H. Goss
Source :
Journal of Cystic Fibrosis. 12(2):99-101
Publication Year :
2013
Publisher :
Elsevier BV, 2013.

Abstract

Many new therapies are emerging for the treatment of CF. In the last 2 years, six agents have been approved by the Food and Drug Administration (FDA) and four agents have given an opinion in favor of granting a marketing authorization by the European Medicines Agency (EMA) representing dramatic results from decades of investment in basic and clinical science. In this month's journal, Assael and colleagues present data from a phase 3 open-label, randomized, parallel-group, active-comparator non-inferiority trial comparing aztreonam for inhalation solution (AZLI) and inhaled tobramycin nebulizer solution (TNS)...

Details

ISSN :
15691993
Volume :
12
Issue :
2
Database :
OpenAIRE
Journal :
Journal of Cystic Fibrosis
Accession number :
edsair.doi.dedup.....f9c6a39c2875abc98d5ddba0299ba6fd
Full Text :
https://doi.org/10.1016/j.jcf.2012.08.006