Vosevi

Product manufactured by Gilead Sciences, Inc.

Application Nr Approved Date Route Status External Links
NDA209195 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Vosevi Is Indicated For The Treatment Of Adult Patients With Chronic Hepatitis C Virus (hcv) Infection Without Cirrhosis Or With Compensated Cirrhosis (child-Pugh A) Who Have [see Dosage And Administration (2.2) And Clinical Studies (14) ]: Genotype 1, 2, 3, 4, 5, Or 6 Infection And Have Previously Been Treated With An Hcv Regimen Containing An Ns5a Inhibitor. Genotype 1a Or 3 Infection And Have Previously Been Treated With An Hcv Regimen Containing Sofosbuvir Without An Ns5a Inhibitor. Additional Benefit Of Vosevi Over Sofosbuvir/velpatasvir Was Not Shown In Adults With Genotype 1b, 2, 4, 5, Or 6 Infection Previously Treated With Sofosbuvir Without An Ns5a Inhibitor. Vosevi Is A Fixed-Dose Combination Of Sofosbuvir, A Hepatitis C Virus (hcv) Nucleotide Analog Ns5b Polymerase Inhibitor, Velpatasvir, An Hcv Ns5a Inhibitor, And Voxilaprevir, An Hcv Ns3/4a Protease Inhibitor, And Is Indicated For The Treatment Of Adult Patients With Chronic Hcv Infection Without Cirrhosis Or With Compensated Cirrhosis (child-Pugh A) Who Have ( 1 , 2.2 , 14 ): Genotype 1, 2, 3, 4, 5, Or 6 Infection And Have Previously Been Treated With An Hcv Regimen Containing An Ns5a Inhibitor. Genotype 1a Or 3 Infection And Have Previously Been Treated With An Hcv Regimen Containing Sofosbuvir Without An Ns5a Inhibitor. Additional Benefit Of Vosevi Over Sofosbuvir/velpatasvir Was Not Shown In Adults With Genotype 1b, 2, 4, 5, Or 6 Infection Previously Treated With Sofosbuvir Without An Ns5a Inhibitor.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 3 Total)

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