Sovaldi

Product manufactured by Gilead Sciences, Inc.

Application Nr Approved Date Route Status External Links
NDA204671 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sovaldi Is A Hepatitis C Virus (Hcv) Nucleotide Analog Ns5b Polymerase Inhibitor Indicated For The Treatment Of: Adult Patients With Genotype 1, 2, 3 Or 4 Chronic Hcv Infection Without Cirrhosis Or With Compensated Cirrhosis As A Component Of A Combination Antiviral Treatment Regimen. ( 1 ) Pediatric Patients 3 Years Of Age And Older With Genotype 2 Or 3 Chronic Hcv Infection Without Cirrhosis Or With Compensated Cirrhosis In Combination With Ribavirin. ( 1 ) Adult Patients: Sovaldi Is Indicated For The Treatment Of Adult Patients With Chronic Hepatitis C Virus (Hcv) Infection As A Component Of A Combination Antiviral Treatment Regimen [See Dosage And Administration (2.2) , And Clinical Studies (14) ] Genotype 1 Or 4 Infection Without Cirrhosis Or With Compensated Cirrhosis For Use In Combination With Pegylated Interferon And Ribavirin Genotype 2 Or 3 Infection Without Cirrhosis Or With Compensated Cirrhosis For Use In Combination With Ribavirin. Pediatric Patients: Sovaldi Is Indicated For The Treatment Of Chronic Hcv Genotype 2 Or 3 Infection In Pediatric Patients 3 Years Of Age And Older Without Cirrhosis Or With Compensated Cirrhosis For Use In Combination With Ribavirin [See Dosage And Administration (2.3) And Clinical Studies (14.5) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sofosbuvir SOFOSBUVIR ZINC100074252

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