The US Food and Drug Administration (FDA) today posted briefing materials in advance of 2 June 2010 Antiviral Drugs Advisory Committee to discuss the approval of motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.The briefing materials can be found on the FDA web site.
In December 2009, AstraZeneca announced that MedImmune, its biologics unit, had filed its formal regulatory reply to a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). MedImmune received the CRL asking for additional information regarding motavizumab on 25 November 2008.
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