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news.AstraZeneca has announced that MedImmune, its wholly owned biologics business, has received a complete response letter from the FDA asking for additional information on motavizumab.
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The complete response letter is in connection with the biologics license application for motavizumab for the prevention of serious respiratory syncytial virus disease, which was submitted in January 2008. Motavizumab is an investigational monoclonal antibody.
MedImmune will continue discussions with the FDA reviewers and, subject to this dialog, currently expects to resubmit in the first half of 2009, said AstraZeneca.