Lamivudine

Product manufactured by Prasco Laboratories

Application Nr Approved Date Route Status External Links
NDA021003 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lamivudine Tablets (Hbv) Are Indicated For The Treatment Of Chronic Hepatitis B Virus (Hbv) Infection Associated With Evidence Of Hepatitis B Viral Replication And Active Liver Inflammation [See Clinical Studies ( 14.1 , 14.2 )]. The Following Points Should Be Considered When Initiating Therapy With Lamivudine Tablets (Hbv): • Due To High Rates Of Resistance Development In Treated Patients, Initiation Of Treatment With Lamivudine Tablets (Hbv) Should Only Be Considered When The Use Of An Alternative Antiviral Agent With A Higher Genetic Barrier To Resistance Is Not Available Or Appropriate. • Lamivudine Tablets (Hbv) Have Not Been Evaluated In Patients Co-Infected With Hiv, Hepatitis C Virus (Hcv), Or Hepatitis Delta Virus. • Lamivudine Tablets (Hbv) Have Not Been Evaluated In Liver Transplant Recipients Or In Patients With Chronic Hepatitis B Virus Infection With Decompensated Liver Disease. Lamivudine Tablets (Hbv) Are A Nucleoside Analogue Reverse Transcriptase Inhibitor Indicated For The Treatment Of Chronic Hepatitis B Virus Infection Associated With Evidence Of Hepatitis B Viral Replication And Active Liver Inflammation. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lamivudine LAMIVUDINE ZINC12346

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