XOFLUZA

批准信原文要点

These Prior Approval supplemental new drug applications provide for… use of Xofluza, for oral suspension 30 mg and 40 mg packet presentations… a new 30 mg dosing regimen for patients weighing greater than 15 kg to less than 20 kg… update the Patient Information… Instructions for Use for Xofluza for oral suspension that is provided in packets.

批准信原文要点

These Prior Approval supplemental new drug applications provide for the following: • To update the Prescribing Information with additional information regarding pediatric patients from birth to < 1 year of age

批准信原文要点

These Prior Approval sNDAs update the US Prescribing Information (PI) with information to: Expand the patient population to include the treatment of pediatric patients between the ages of 5 to <12 years old with acute uncomplicated influenza who are at high risk of developing influenza-related complications.

批准信原文要点

These Prior Approval supplemental new drug applications provide for updates to the CLINICAL PHARMACOLOGY, Microbiology, Resistance subsection of labeling. Updated information includes the addition of treatment-emergent polymerase acidic (PA) amino acid substitutions and PA amino acid substitutions identified in surveillance and cell culture resistance studies that were associated with reduced susceptibility to baloxavir.

批准信原文要点

NDA 210854/S-09 The use of Xofluza (baloxavir marboxil) tablets for post-exposure prophylaxis of influenza in pediatric patients ≥ 5 to less than 12 years of age

批准信原文要点

NDA 210854/S-05 The use of Xofluza (baloxavir marboxil) tablets for the treatment of influenza in pediatric patients ≥ 5 to less than 12 years of age

批准信原文要点

These Prior Approval supplemental new drug applications provide for the following changes: • To provide the use of Xofluza, for oral suspension 30 mg and 40 mg packet presentations • To provide a new 30 mg dosing regimen for patients weighing greater than 15 kg to less than 20 kg

批准信原文要点

NDA 210854/S-10 To update CLINICAL PHARMACOLOGY, Microbiology, Resistance subsection with data from 3 treatment trials in pediatric patients 12 months to less than 12 years of age.

批准信原文要点

NDA 210854/S-04 To expand the indication for XOFLUZA (baloxavir marboxil) tablets to include post-exposure prophylaxis of influenza in adults and pediatric patients 12 years of age and older

批准信原文要点

This supplemental application provides for the following updates to the content of labeling and the carton and container labeling: • Revise INDICATIONS AND USAGE, ADVERSE REACTIONS, USE IN SPECIFIC POPULATIONS, and CLINICAL STUDIES sections with data to support the use of XOFLUZA for the treatment of acute uncomplicated influenza in patients 12 years of age or older, who have been symptomatic for no more than 48 hours and are at high risk of developing influenza-related complications;