Application Nr Approved Date Route Status External Links
NDA210854 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Xofluza™ Is Indicated For The Treatment Of Acute Uncomplicated Influenza In Patients 12 Years Of Age And Older Who Have Been Symptomatic For No More Than 48 Hours. Xofluza™ Is A Polymerase Acidic (pa) Endonuclease Inhibitor Indicated For The Treatment Of Acute Uncomplicated Influenza In Patients 12 Years Of Age And Older Who Have Been Symptomatic For No More Than 48 Hours. ( 1 ) Limitations Of Use : Influenza Viruses Change Over Time, And Factors Such As The Virus Type Or Subtype, Emergence Of Resistance, Or Changes In Viral Virulence Could Diminish The Clinical Benefit Of Antiviral Drugs. Consider Available Information On Drug Susceptibility Patterns For Circulating Influenza Virus Strains When Deciding Whether To Use Xofluza. ( 1 ) Limitations Of Use: Influenza Viruses Change Over Time, And Factors Such As The Virus Type Or Subtype, Emergence Of Resistance, Or Changes In Viral Virulence Could Diminish The Clinical Benefit Of Antiviral Drugs. Consider Available Information On Drug Susceptibility Patterns For Circulating Influenza Virus Strains When Deciding Whether To Use Xofluza [see Microbiology (12.4) And Clinical Studies (14) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Baloxavir Marboxil

Comments