Application Nr Approved Date Route Status External Links
NDA210806 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pifeltro ™ Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adult Patients: With No Prior Antiretroviral Treatment History; Or To Replace The Current Antiretroviral Regimen In Those Who Are Virologically Suppressed (Hiv-1 Rna Less Than 50 Copies Per Ml) On A Stable Antiretroviral Regimen With No History Of Treatment Failure And No Known Substitutions Associated With Resistance To Doravirine [See Clinical Studies (14) ] . Pifeltro, A Non-Nucleoside Reverse Transcriptase Inhibitor (Nnrti), Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adult Patients: With No Prior Antiretroviral Treatment History, Or To Replace The Current Antiretroviral Regimen In Those Who Are Virologically Suppressed (Hiv-1 Rna Less Than 50 Copies Per Ml) On A Stable Antiretroviral Regimen With No History Of Treatment Failure And No Known Substitutions Associated With Resistance To Doravirine. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Doravirine DORAVIRINE ZINC72317283

Comments