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US paediatric panel to review adverse events for 11 drugs

This article was originally published in Scrip

Executive Summary

The US FDA's paediatric advisory panel will meet on November 18th to review adverse event reports for 11 drugs under the Best Pharmaceuticals for Children Act. The medicines areAlcon's Betoptic S (betaxolol), Graceway Pharmaceuticals' Aldara (imiquimod),GlaxoSmithKline's Lamictal (lamotrigine),Johnson & Johnson's Levaquin (levofloxacin),Novartis's Sandostatin (octreotide),Lilly's Zyprexa (olanzapine), J&J's Risperdal (risperidone), Novartis's Lamisil (terbinafine), Falcon Pharmaceuticals' Timolol GFS (timolol) andSanofi-Aventis's Ambien (zolpidem). The panel also will be given a written follow-up report onPfizer's Zyvox (linezolid), as requested at a November 2006 meeting.

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