Glaxo Relenza Indication Limited to Children 7 And Up By FDA Data Analysis
This article was originally published in Pharmaceutical Approvals Monthly
Glaxo Wellcome’s Relenza (zanamivir) gained approval for a pediatric indication to treat influenza in children ages 7 to 11 instead of the indication submitted by the company for children 5 and up, because of findings of an FDA age-specific analysis and pharmacokinetic data, according to review documents.
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