FDA Uncertain About GSK’s Serevent Pediatric Risk-Benefit Ratio
This article was originally published in The Pink Sheet Daily
Executive Summary
Pediatric Advisory Committee will review adverse events data for the asthma treatment Serevent and the adequacy of pediatric risk information in the drug’s labeling.
You may also be interested in...
Risk/Benefit Of Asthma Drugs To Be Debated At Future Advisory Committee
FDA awaits data from controlled trials of seven long-acting beta agonists before bringing them back for panel review later this year.
Risk/Benefit Of Asthma Drugs To Be Debated At Future Advisory Committee
FDA awaits data from controlled trials of seven long-acting beta agonists before bringing them back for panel review later this year.
FDA Panel Suggests Adding Pediatric Risk Warning To GSK’s Serevent Label
Pediatric Advisory Committee also suggests changes in Cephalon’s Provigil label that exclude use in pediatric population.