FDA Webview
X

Free FDA Notices

Pediatric Panel to Discuss AERs on 10 Products

10/15/2008

Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 11/18, from 8 a.m. to 5 p.m. at the Holiday Inn Gaithersburg, 2 Montgomery Village Rd., Gaithersburg, MD. Contact Carlos Peña, (301) 827-3340. The committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act on adverse event reports for Betoptic S (betaxolol), Aldara (imiquimod), Lamictal (lamotrigine), Levaquin (levofloxacin), Sandostatin (octreotide), Zyprexa (olanzapine), Risperdal (risperidone), Lamisil (terbinafine), Timolol GFS (timolol), and Ambien (zolpidem). The committee will be provided a written follow-up report on Zyvox (linezolid), as requested by the committee at the 11/16/06 Pediatric Advisory Committee meeting. To view this notice, click here.

LATEST NEWS