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Glaxo Relenza

Executive Summary

FDA grants a three-month extension to the review of zanamivir following discussions with Glaxo about comments and suggestions made by the Antiviral Drugs Advisory Committee in February. The advisory committee voted that Relenza had not been shown to be safe and effective for the treatment of influenza ("The Pink Sheet" March 1, p. 3). The original estimated user fee goal for Relenza was April 1999

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