A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Latest Information Update: 12 Apr 2017
At a glance
- Drugs DR 5001 (Primary)
- Indications Adenovirus infections; Lung disorders
- Focus Pharmacodynamics
- Sponsors Duramed Pharmaceuticals Inc
- 24 May 2012 Actual patient number 4041 added as reported by ClinicalTrials.gov.
- 11 Dec 2008 BLA based on this trial accepted for review by the US FDA, reported by a Barr media release.
- 19 Nov 2006 New trial record.