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Home » FDA SEEKS PEDIATRIC DRUG STUDIES FOR POSSIBLE LABEL CHANGES
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FDA SEEKS PEDIATRIC DRUG STUDIES FOR POSSIBLE LABEL CHANGES
April 19, 2004
The FDA has referred Elan Pharmaceuticals’ Zonegran, GlaxoSmithKline’s (GSK) Wellbutrin and Zyban and GelTex Pharmaceuticals’ Renagel to the Foundation for the National Institutes of Health (NIH) for pediatric studies that potentially could lead to new labeling for relevant pediatric populations.