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Motavizumab FDA Approval Status

FDA Approved: No
Generic name: motavizumab
Company: MedImmune, Inc.
Treatment for: RSV

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

Sep  7, 2010Medimmune Receives Complete Response Letter On Motavizumab
Jun  3, 2010FDA Advisory Committee Reviews MedImmune's Motavizumab
Dec  1, 2008MedImmune Receives FDA Complete Response Letter on Motavizumab
Feb  4, 2008MedImmune Submits Biologics License Application to FDA for Motavizumab

Further information

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