Application Nr Approved Date Route Status External Links
ANDA077224 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ribavirin Is A Nucleoside Analogue Indicated In Combination With Interferon Alfa- 2b (Pegylated And Nonpegylated) For The Treatment Of Chronic Hepatitis C (Chc) In Patients 3 Years Of Age Or Older With Compensated Liver Disease. ( 1.1 ) Patients With The Following Characteristics Are Less Likely To Benefit From Re-Treatment After Failing A Course Of Therapy: Previous Nonresponse, Previous Pegylated Interferon Treatment, Significant Bridging Fibrosis Or Cirrhosis, And Genotype 1 Infection. 1.1 Chronic Hepatitis C (Chc) Ribavirin Capsules In Combination With Interferon Alfa-2b (Pegylated And Nonpegylated) Is Indicated For The Treatment Of Chronic Hepatitis C (Chc) In Patients 3 Years Of Age And Older With Compensated Liver Disease [See Warnings And Precautions ( 5.9 , 5.10 ), And Use In Specific Populations ( 8.4 )]. The Following Points Should Be Considered When Initiating Ribavirin Capsules Combination Therapy With Pegintron ® Or Intron A ® : Combination Therapy With Ribavirin /pegintron Is Preferred Over Ribavirin /intron A As This Combination Provides Substantially Better Response Rates [See Clinical Studies ( 14 ) ]. Patients With The Following Characteristics Are Less Likely To Benefit From Retreatment After Failing A Course Of Therapy: Previous Nonresponse, Previous Pegylated Interferon Treatment, Significant Bridging Fibrosis Or Cirrhosis, And Genotype 1 Infection [See Clinical Studies ( 14 ) ]. No Safety And Efficacy Data Are Available For Treatment Duration Lasting Longer Than One Year.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ribavirin RIBAVIRIN ZINC1035331

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