Motavizumab FDA Approval Status
FDA Approved: No
Generic name: motavizumab
Company: MedImmune, Inc.
Treatment for: Respiratory Syncytial Virus
Motavizumab is an investigational monoclonal antibody (MAb) for the prevention of serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients.
In September 2010, MedImmune, Inc. announced the receipt of a second Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for motavizumab had not been approved.
Development timeline for motavizumab
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