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... 21, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Kogenate FS (antihemophilic factor (recombinant )), Casodex (bicalutamide ), Apidra (insulin glulisine [rDNA ]), NovoLog (insulin aspart [rDNA ]), Arimidex (anastrozole ), Desmopressin Acetate, Prevacid (lansoprazole ), Nexium (esomeprazole magnesium ), Aciphex (rabeprazole sodium ), Prilosec (omeprazole ), OraVerse (phentolamine mesylate ), Zemuron (rocuronium bromide). The committee will also receive a followup presentation on Suprane (desflurane). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http :// www.fda.gov / AdvisoryCommittees / Calendar / default.htm. Scroll down to the appropriate advisory committee link ...
URL: http://edocket.access.gpo.gov/2010/2010-11038.htm

 

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