Symtuza

Product manufactured by Janssen Products Lp

Application Nr Approved Date Route Status External Links
NDA210455 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Symtuza Is Indicated As A Complete Regimen For The Treatment Of Human Immunodeficiency Virus Type 1 (hiv-1) Infection In Adults And Pediatric Patients Weighing At Least 40 Kg: Who Have No Prior Antiretroviral Treatment History Or Who Are Virologically Suppressed (hiv-1 Rna Less Than 50 Copies Per Ml) On A Stable Antiretroviral Regimen For At Least 6 Months And Have No Known Substitutions Associated With Resistance To Darunavir Or Tenofovir. Symtuza Is A Four-Drug Combination Of Darunavir (drv), A Human Immunodeficiency Virus (hiv-1) Protease Inhibitor, Cobicistat (cobi), A Cyp3a Inhibitor, And Emtricitabine (ftc) And Tenofovir Alafenamide (taf), Both Hiv-1 Nucleoside Analog Reverse Transcriptase Inhibitors, And Is Indicated As A Complete Regimen For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 40 Kg: Who Have No Prior Antiretroviral Treatment History Or Who Are Virologically Suppressed (hiv-1 Rna Less Than 50 Copies Per Ml) On A Stable Antiretroviral Regimen For At Least 6 Months And Have No Known Substitutions Associated With Resistance To Darunavir Or Tenofovir. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 4 Total)

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