Stribild

Product manufactured by Gilead Sciences, Inc.

Application Nr Approved Date Route Status External Links
NDA203100 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Stribild ® Is Indicated As A Complete Regimen For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 12 Years Of Age And Older Weighing At Least 35 Kg Who Have No Antiretroviral Treatment History Or To Replace The Current Antiretroviral Regimen In Those Who Are Virologically Suppressed (hiv-1 Rna Less Than 50 Copies/ml) On A Stable Antiretroviral Regimen For At Least 6 Months With No History Of Treatment Failure And No Known Substitutions Associated With Resistance To The Individual Components Of Stribild [see Clinical Studies (14) ] . Stribild Is A Four-Drug Combination Of Elvitegravir, An Hiv Integrase Strand Transfer Inhibitor (hiv-1 Insti), Cobicistat, A Cyp3a Inhibitor, And Emtricitabine And Tenofovir Disoproxil Fumarate (tdf), Both Hiv Nucleoside Analog Reverse Transcriptase Inhibitors (hiv Nrti) And Is Indicated As A Complete Regimen For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 12 Years Of Age And Older Weighing At Least 35 Kg Who Have No Antiretroviral Treatment History Or To Replace The Current Antiretroviral Regimen In Those Who Are Virologically Suppressed (hiv-1 Rna Less Than 50 Copies/ml) On A Stable Antiretroviral Regimen For At Least 6 Months With No History Of Treatment Failure And No Known Substitutions Associated With Resistance To The Individual Components Of Stribild. ( 1 , 14 )

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