Ribavirin

Product manufactured by Sandoz Inc

Application Nr Approved Date Route Status External Links
ANDA076192 2004-04-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ribavirin Capsules Usp Are A Nucleoside Analogue Indicated In Combination With Interferon Alfa-2b 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 Retreatment 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 Usp In Combination With Interferon Alfa-2b (nonpegylated) Are 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 Combination Therapy With Intron A: •these Indications Are Based On Achieving Undetectable Hcv-Rna After Treatment For 24 Or 48 Weeks And Maintaining A Sustained Virologic Response (svr) 24 Weeks After The Last Dose. •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 Of Longer Than One Year.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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