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Aztreonam for inhalation solution, challenges to drug approval and integration into CF care
- 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)...
- Subjects :
- Male
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Cystic Fibrosis
Clinical science
Aztreonam
Marketing authorization
01 natural sciences
Food and drug administration
010104 statistics & probability
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Drug approval
medicine
Humans
Pseudomonas Infections
030212 general & internal medicine
Pediatrics, Perinatology, and Child Health
0101 mathematics
Intensive care medicine
health care economics and organizations
Inhalation Solution
Nebulizer Solution
business.industry
Anti-Bacterial Agents
3. Good health
Inhaled tobramycin
chemistry
Pediatrics, Perinatology and Child Health
Tobramycin
Female
business
Subjects
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