Tamiflu U.S. Labeling Adopts Japanese Warnings
This article was originally published in The Pink Sheet Daily
Executive Summary
Neuropsychiatric adverse event reports for Roche's antiviral jump in most recent review, prompting FDA staff to suggest a labeling change.
You may also be interested in...
FDA Recommends Precautionary Language On Neuropsychiatric Events For Tamiflu
Agency’s Pediatric Advisory Committee will also evaluate updated adverse event data from the 2006-2007 flu season for GSK’s Relenza.
FDA Recommends Precautionary Language On Neuropsychiatric Events For Tamiflu
Agency’s Pediatric Advisory Committee will also evaluate updated adverse event data from the 2006-2007 flu season for GSK’s Relenza.
Tamiflu Safety Will Get FDA Committee Review Nov. 27
The Pediatric Advisory Committee will evaluate reported neuropsychiatric and behavioral events from patients taking Roche’s influenza product.